ClinicalTrials.gg
Not yet recruitingNCT07561073Updated Oct 15, 2026

Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial

An interventional study of stomach-partitioning gastrojejunostomy and conventional gastrojejunostomy in Gastric Cancer and Gastric Outlet Obstruction, sponsored by Guangxi Medical University. Not yet recruiting at 3 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Guangxi Medical University · Not applicable, Interventional, and Treatment

Updated Oct 7, 2026Now Not yet recruitingResults publication added+7 moreGo to Updates ↓

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Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 1,183 studies in Stomach Neoplasms with a site in China — 480 open to participants now, 556 under way, 50 of them phase 3. Stomach Neoplasms · China.

Planned enrollment
453rd of 880
80 · median 87
Started
2026
with 91 others
No phase
221 of 1,183
95 open now
Primary completion
2029-01
later than 508 of 555 live
Registered
1,124th of 1,183
by date

Among the 1,183 studies in Stomach Neoplasms with a site in China, this one is the 453rd largest by planned enrollment of the 880 interventional ones that give a count, is one of 92 that started in 2026, is one of 221 with no phase, reaches primary completion later than 508 of the 555 other live ones, and was the 1,124th registered.

Stomach Neoplasms

3,401 studies on the registry are indexed under Stomach Neoplasms; 993 are open to participants now.

Browse Stomach Neoplasms studies →

Open to participants now

480 of the 1,183 studies in Stomach Neoplasms with a site in China are open now. Recruiting first, the newest first:

475 more — sign in →

All 480 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 704 Stomach Neoplasms studies recruiting now, 376 (53%) set no upper age limit and 194 (28%) stop at 75 or younger; 28 take children under 18; 69 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 1,183 studies in Stomach Neoplasms with a site in China, or all of them as a file.
02

Study summary

Gastric outlet obstruction (GOO) complicates locally advanced or metastatic gastric cancer and severely impairs oral intake, nutritional status, and quality of life. Conventional gastrojejunostomy (CGJ) effectively relieves the obstruction but is associated with a high incidence of delayed gastric emptying (DGE), which delays the resumption of oral intake and the initiation of systemic anticancer therapy. Stomach-partitioning gastrojejunostomy (SPGJ) isolates the tumour-bearing distal stomach from the alimentary tract and has been suggested, in retrospective studies, to reduce the incidence of DGE. However, the only randomized comparison reported to date was a small monocentric trial that assessed oral intake acceptance rather than gastric emptying. The comparative effect of SPGJ and CGJ on delayed gastric emptying therefore remains untested in a randomized setting. This multicenter, randomized, open-label, blinded-outcome-assessment trial will randomly assign 80 participants with unresectable distal gastric adenocarcinoma complicated by GOO, in a 1:1 ratio, to undergo either SPGJ or CGJ. The primary endpoint is the incidence of postoperative DGE within 30 days after surgery.

Read the detailed description

This is a prospective, multicenter, randomized, open-label superiority trial with blinded outcome assessment, conducted at three tertiary referral hospitals in Guangxi, China (Guangxi Medical University Cancer Hospital, Wuzhou Red Cross Hospital, and Guangxi Medical University Wuming Hospital). The coordinating center is Guangxi Medical University Cancer Hospital.

Eligible participants will be randomly assigned in a 1:1 ratio to undergo either stomach-partitioning gastrojejunostomy (SPGJ) or conventional gastrojejunostomy (CGJ), using a computer-generated allocation sequence with variable block sizes, stratified by participating centre. The allocation sequence will be generated centrally by an independent statistician and implemented through a centralized, password-protected randomization system. Allocation will remain concealed until eligibility has been confirmed and written informed consent has been obtained.

Surgical procedures cannot be blinded. Outcome assessors (including the radiologist assessing the primary endpoint), research staff collecting patient-reported outcomes, and the statistician performing the prespecified analyses will be blinded to treatment allocation.

In both groups, a laparoscopic approach will be preferred and routine diagnostic laparoscopy will be performed to confirm surgical eligibility. Gastrointestinal reconstruction will use a standardized isoperistaltic configuration; Braun enteroenterostomy and Roux-en-Y reconstruction will not be performed.

In the SPGJ group, partial gastric transection will be performed using a linear cutting stapler, beginning at the greater curvature, at the junction of the gastric body and antrum or approximately 5 cm proximal to the superior margin of the tumour, preserving a 2-3 cm-wide gastric channel along the lesser curvature. A side-to-side gastrojejunostomy will be constructed between the posterior wall of the proximal gastric segment at the greater curvature and the antimesenteric border of the jejunum 5-10 cm distal to the ligament of Treitz, via an antecolic route. The common enterotomy will be closed with a linear stapler or hand-sewn sutures.

In the CGJ group, a side-to-side gastrojejunostomy will be constructed via an antecolic route between the most dependent portion of the greater curvature of the stomach and the proximal jejunum 5-10 cm distal to the ligament of Treitz. The common enterotomy will be closed with a linear stapler or hand-sewn sutures.

Both groups will receive a standardized perioperative management protocol. Participants will be assessed daily for DGE-related signs from postoperative day (POD) 1 to POD 7, with formal DGE assessments on POD 3, 7, 14 and 21, and a further assessment at the 30-day postoperative visit. After the 30-day safety visit, follow-up will be performed every 3 months. A prespecified analysis of overall survival will be performed at 12 months after surgery.

03

Conditions studied

  • Gastric Cancer
  • Gastric Outlet Obstruction

Keywords

  • Gastric cancer
  • conventional gastrojejunostomy
  • gastric outlet obstruction
  • stomach-partitioning gastrojejunostomy
  • delayed gastric emptying
  • randomized controlled trial
04

Who can participate

The criteria were revised on the registry on Oct 7, 2026. See what changed

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients and their family members must be fully informed of the study procedures and voluntarily provide written prior to enrollment.
  2. Age 18-75 years (inclusive).
  3. confirmed distal gastric adenocarcinoma deemed unresectable due to locally advanced disease, distant , or peritoneal dissemination (cT4bM0 or T3-4M1, regardless of the clinical lymph node status, stage IV), and therefore unsuitable for curative resection.
  4. Presence of gastrointestinal obstruction confirmed by upper gastrointestinal contrast radiography or endoscopy, manifested as gastric retention with a Gastric Outlet Obstruction Scoring System (GOOSS) score \<= 1.
  5. (ECOG) performance status of 0-2 without deterioration within 7 days prior to enrollment.
  6. (ASA) physical status classification I-III.
  7. No prior antitumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.

Exclusion criteria

Exclusion Criteria:

  1. Inability or unwillingness to comply with the study protocol or required study procedures.
  2. History of another within 5 years prior to enrollment, with the exception of adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix following curative therapy.
  3. Active disease within 4 weeks prior to enrollment or a documented history of autoimmune disease.
  4. Prior bone marrow transplantation or solid organ transplantation.
  5. cardiovascular disease, including but not limited to: acute myocardial infarction, severe or unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure classified as (NYHA) functional class > II; ventricular arrhythmias requiring pharmacologic treatment; or (LVEF) \< 50%.
  6. Active or uncontrolled severe infection, defined as grade >= 2 according to the (CTCAE) version 5.0.
  7. Known (HIV) infection, or a history of clinically significant liver disease, including viral hepatitis: known virus (HBV) carriers must be excluded if active HBV infection is present, defined as HBV DNA positivity (> 1 x 10\^4 copies/mL or > 2000 IU/mL); known virus (HCV) infection with positive HCV RNA (> 1 x 10\^3 copies/mL).
  8. Pregnant women (positive pregnancy test prior to treatment initiation) or lactating women.
  9. Any other disease, clinically significant metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the judgment of the investigator, may render the patient unsuitable for study participation (e.g., uncontrolled seizure disorder requiring treatment), interfere with the interpretation of study results, or place the patient at undue risk.
  10. Any condition that, in the opinion of the investigator, makes the patient inappropriate for inclusion in this trial.
Terms in these criteria, in plain language(15)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    stomach-partitioning gastrojejunostomy (SPGJ)

    Participants undergo laparoscopic stomach-partitioning gastrojejunostomy. The gastric body is partially transected with a linear cutting stapler, beginning at the greater curvature, at the junction of the gastric body and antrum or approximately 5 cm proximal to the superior margin of the tumour, preserving a 2-3 cm-wide gastric channel along the lesser curvature. A side-to-side gastrojejunostomy is constructed between the posterior wall of the proximal gastric segment and the antimesenteric border of the jejunum 5-10 cm distal to the ligament of Treitz, via an antecolic route, in an isoperistaltic orientation. The common enterotomy is closed with a linear stapler or hand-sewn sutures.

    Procedure: stomach-partitioning gastrojejunostomy

  • Active comparator
    conventional gastrojejunostomy (CGJ)

    Participants undergo laparoscopic conventional gastrojejunostomy. A side-to-side anastomosis is constructed via an antecolic route between the most dependent portion of the greater curvature of the stomach and the proximal jejunum 5-10 cm distal to the ligament of Treitz, in an isoperistaltic orientation. The common enterotomy is closed with a linear stapler or hand-sewn sutures.

    Procedure: conventional gastrojejunostomy

Interventions

  • Procedurestomach-partitioning gastrojejunostomy

    At the junction of the gastric body and the antrum, or about 5cm from the upper edge of the tumor, a straight-line cutting closure device was used to cut off part of the gastric body from the greater curvature of the stomach to form a partition, and a 2-3cm wide gastric body near the lesser curvature was retained. A hole was made in the greater curvature of the posterior gastric wall at the proximal end of the septum, and a hole was made in the jejunum-to-mesenteric margin 5-10 cm from the Treitz ligament. A linear cutting closure device was placed through the transverse colon. The greater curvature-jejunum side-to-side anastomosis of the posterior gastric wall with pro-peristalsis or anti-peristalsis was performed, and the common opening was closed by using a linear cutting closure device or suture.

    Also known as: Conventional gastrojejunostomy

  • Procedureconventional gastrojejunostomy

    The lowest point of the greater curvature of the stomach and the proximal jejunum 5-10 cm away from the Treitz ligament were subjected to side-to-side anastomosis of peristaltic or anti-peristaltic using a linear cutter before the transverse colon, and the common opening was closed using a linear cutter or suture.

06

What researchers measure

Primary outcomes

  1. Incidence of delayed gastric emptying(DGE)

    Delayed gastric emptying (DGE) is defined as impaired progression of oral intake, persistent or recurrent vomiting, abdominal distension, or prolonged or recurrent need for nasogastric tube (NGT) decompression, after mechanical causes (anastomotic stenosis or oedema, intestinal kinking or torsion, afferent or efferent limb obstruction) and other postoperative complications (postoperative ileus, anastomotic leakage, intra-abdominal infection, bleeding, tumour progression) have been considered and excluded where clinically appropriate. Severity is graded according to criteria adapted from the International Study Group of Pancreatic Surgery (ISGPS).

    Time frame: Within 30 days after surgery

Secondary outcomes

  1. Time to postoperative gastrointestinal functional recovery

    Time from surgery to the first occurrence of both passage of flatus and tolerance of a semi-liquid diet without vomiting or need for nasogastric tube decompression.

    Time frame: Within 30 days after surgery

  2. Nutritional status

    Nutritional status assessed by the Patient-Generated Subjective Global Assessment (PG-SGA) score. PG-SGA assessment table contains seven aspects, which are divided into two parts : the patient self-assessment part ( A score ) and the medical staff assessment part ( B + C + D score ). The total score is obtained by adding the two parts.

    Time frame: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy

  3. Health-related quality of life

    Health-related quality of life assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the gastric cancer-specific module QLQ-STO22. Scores are standardised to a 0-100 scale.

    Time frame: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy

  4. Incidence of early postoperative complications

    Proportion of participants experiencing any postoperative complication graded Clavien-Dindo grade II or above, or any adverse event graded CTCAE v5.0 grade 2 or above, within 30 days after surgery.

    Time frame: Within 30 days after surgery

  5. Incidence of late postoperative complications

    Proportion of participants experiencing any postoperative complication occurring from 30 days to 12 months after surgery.

    Time frame: From 30 days to 12 months after surgery

  6. Incidence of anastomotic complications

    Proportion of participants experiencing anastomotic leakage, anastomotic stenosis, or anastomotic bleeding.

    Time frame: Within 12 months after surgery

  7. Postoperative mortality

    Proportion of participants who die from any cause within 30 days and within 90 days after surgery.

    Time frame: 30 days and 90 days after surgery

  8. Initiation of subsequent systemic therapy

    Proportion of participants initiating systemic anticancer therapy after surgery, and time from surgery to initiation.

    Time frame: Within 12 months after surgery

  9. Overall survival (OS)

    Overall survival, defined as the time from surgery to death from any cause; participants alive at the prespecified analysis time point are censored at the date of last follow-up.

    Time frame: Up to 12 months after surgery

07

Study locations

3 sites
08

References and documents

Publications

  • Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (GO-PART Study, KLASS 16)

Individual participant data

Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication may be made available by the corresponding author upon reasonable request. Requests will be subject to approval by the principal investigator and the institutional ethics committee, compliance with applicable institutional and regulatory requirements, and execution of a data-sharing agreement.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jan 2029, 27 months later.

Of 356 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 66. This study's planned 27 months is below that.

Counting every sponsor, half of 367 studies reached it within 36 months; a quarter within 17 and three quarters within 63.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 7, 2026: primary completion Jan 2028 → Jan 2029 and completion Jan 2029 → Mar 2029.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Apr 26, 2026
First posted
May 1, 2026
StartEst.
Oct 20, 2026
Primary completionEst.
Jan 31, 2029was Jan 2028
CompletionEst.
Mar 31, 2029was Jan 2029
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Not yet recruiting
changed Oct 7, 2026
Sites
2 sites added
Show 2 added (2 China)
  • Wuzhou Red Cross Hospital · Wuzhou, China
  • Wuming Hospital of Guangxi Medical University · Nanning, China
Oct 7, 2026
Primary completion
Jan 1, 2028→Jan 31, 2029
Oct 7, 2026
Study completion
Jan 1, 2029→Mar 31, 2029
Oct 7, 2026
Eligibility
7 inclusion criteria added, 3 removed; 7 exclusion criteria edited, 3 added, 2 removed
What changed in the criteria
Inclusion criteria
  • Removed1.Patients and their families were fully aware of this study and voluntarily signed informed consent ; 2.Age 18-75 years old ( including 18 and 75 years old ) ; 3.Distal gastric cancer ( cT4bN + M0 / T3-4N + M1, stage IV ) with locally unresectable, distant metastasis or peritoneal metastasis confirmed by pathology and unable to undergo radical surgery ; 4.Complicated with digestive tract obstruction ( gastric retention confirmed by upper gastrointestinal radiography or gastroscopy, and GOOSS score ≤ 1 ) ; the ECOG score was 0-2 points, and there was no deterioration within 7 days ; 6.ASA score I-III ; 7.No previous anti-tumor therapy ( such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. ) :
  • RemovedThe functions of important organs meet the following requirements :
  • Removedabsolute neutrophil count ≥ 1.5 × 109 / L, white blood cell count ≥ 4.0 × 109/L; (b) Platelet ≥ 100 × 109 / L ; (c) Hemoglobin ≥ 60g / L ; (d) TBIL ≤ 1.5 times ULN ; (e) ALT and AST ≤ 2.5 times ULN ; (f) urea / urea nitrogen ( BUN ) and creatinine ( Cr ) ≤ 1.5 × ULN ( and creatinine clearance rate ( CCr ) ≥ 50mL / min ) ; (g) Left ventricular ejection fraction ( LVEF ) ≥ 50 % ; the corrected QT interval ( QTcF ) by Fridericia method was less than 470 ms. (i) INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN. 9. women of childbearing age need to take effective contraceptive measures ; 10.No other surgical contraindications ; 11.good compliance, with follow-up.
  • AddedPatients and their family members must be fully informed of the study procedures and voluntarily provide written informed consent prior to enrollment.
  • AddedAge 18-75 years (inclusive).
  • AddedPathologically confirmed distal gastric adenocarcinoma deemed unresectable due to locally advanced disease, distant metastasis, or peritoneal dissemination (cT4bM0 or T3-4M1, regardless of the clinical lymph node status, stage IV), and therefore unsuitable for curative resection.
  • AddedPresence of gastrointestinal obstruction confirmed by upper gastrointestinal contrast radiography or endoscopy, manifested as gastric retention with a Gastric Outlet Obstruction Scoring System (GOOSS) score <= 1.
  • AddedEastern Cooperative Oncology Group (ECOG) performance status of 0-2 without deterioration within 7 days prior to enrollment.
  • AddedAmerican Society of Anesthesiologists (ASA) physical status classification I-III.
  • AddedNo prior antitumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
Exclusion criteria
  • RemovedUnable to comply with the research program or research procedures ;
  • AddedInability or unwillingness to comply with the study protocol or required study procedures.
  • EditedPatients with other malignant tumorsHistory of another malignancy within 5 years beforeprior to enrollment, except forwith the exception of adequately treated basal cell carcinoma or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ;of the cervix following curative therapy.
  • ChangedBefore Patients with active autoimmune diseases or a history of autoimmune diseases within 4 weeks before enrollment ;Now Active autoimmune disease within 4 weeks prior to enrollment or a documented history of autoimmune disease.
  • EditedPreviously receivedPrior allogeneic bone marrow transplantation or solid organ transplantation ;.
  • EditedCardiovascular diseases withClinically significant clinical significancecardiovascular disease, including but not limited to: acute myocardial infarction, severe /or unstable angina pectoris, or coronary artery bypass grafting within 6 months beforeprior to enrollment ; congestive heart failure classified as New York Heart Association ( NYHA ) gradefunctional class > 2 II; ventricular arrhythmiaarrhythmias requiring drugpharmacologic treatment ; lVEF (or left ventricular ejection fraction (LVEF) < 50 % ;.
  • ChangedBefore Active or uncontrolled severe infection ( ≥ CTCAE V5.0 grade 2 infection ) ;Now Active or uncontrolled severe infection, defined as grade >= 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
  • EditedKnown human immunodeficiency virus ( HIV ) infection. Patients with known clinical, or a history of clinically significant liver disease, including viral hepatitis [: known as hepatitis B virus ( HBV ) carriers must be excluded fromif active HBV infection is present, that is,defined as HBV DNA positivepositivity ( > 1 × 104x 10\^4 copies / mL or > 2000 IU / ml mL) ; it is known that hepatitis C virus (HCV) infection ( HCV ) andwith positive HCV RNA positive ( > 1 × 103x 10\^3 copies / mL ) ;.
  • EditedpregnantPregnant women (positive pregnancy test positive before medication prior to treatment initiation) or breastfeedinglactating women ;.
  • RemovedAny other disease with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of the researchers, it is reasonable to suspect that the patient has a state that is not suitable for enrollment ( such as having seizures and requiring treatment ), or will affect the interpretation of the results of the study, or put the patient at high risk ; the researchers considered that the patients were not suitable for inclusion in this study.
  • AddedAny other disease, clinically significant metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the judgment of the investigator, may render the patient unsuitable for study participation (e.g., uncontrolled seizure disorder requiring treatment), interfere with the interpretation of study results, or place the patient at undue risk.
  • AddedAny condition that, in the opinion of the investigator, makes the patient inappropriate for inclusion in this trial.
Oct 7, 2026
Interventions
Arm changed stomach-partitioning gastrojejunostomy→stomach-partitioning gastrojejunostomy (SPGJ); conventional gastrojejunostomy→conventional gastrojejunostomy (CGJ)
Oct 7, 2026
Primary outcomes
1 time frame changed, 1 description edited
What changed in the outcomes
  • Time frameIncidence of delayed gastric emptying(DGE)Evaluation time of delayed gastric emptying : day 3, day 7, day 14, day 21.after operation. → Within 30 days after surgery
  • DescriptionIncidence of delayed gastric emptying(DGE): how it is measured was reworded
Oct 7, 2026
Publications
Results publication added: Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (GO-PART Study, KLASS 16)
Oct 7, 2026
Secondary outcomes
Revised in 2 updates
What changed on Oct 7, 2026
  • EditedpostoperativePostoperative mortalityTime frame: Within 90 days after surgery → 30 days and 90 days after surgery
  • EditedOverall survival ( OS )Time frame: Approximately weeks 1 - 2 after surgery → Up to 12 months after surgery
  • AddedIncidence of early postoperative complicationsTime frame: Within 30 days after surgery
  • AddedNutritional statusTime frame: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy
  • AddedIncidence of late postoperative complicationsTime frame: From 30 days to 12 months after surgery
  • AddedIncidence of anastomotic complicationsTime frame: Within 12 months after surgery
  • AddedHealth-related quality of lifeTime frame: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy
  • RemovedPG-SGA scoreTime frame: Approximately 30 days
  • RemovedEarly postoperative complication rateTime frame: Within 21 days after surgery
  • RemovedLate postoperative complication rateTime frame: 21 days after operation
  • RemovedAnastomotic complication rateTime frame: Within 21 days after surgery
  • RemovedLife quality evaluation (QLQ-c30)Time frame: Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
  • Removedother outcomequality of life (QLQ-STO22)Time frame: Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
What changed on Oct 15, 2026
  • AddedTime to postoperative gastrointestinal functional recoveryTime frame: Within 30 days after surgery
  • AddedInitiation of subsequent systemic therapyTime frame: Within 12 months after surgery
across 2 updates, Oct 7, 2026 – Oct 15, 2026
Title
Comparison of Partial Stomach-Partitioning andVersus Conventional Gastrojejunostomy for the Treatment ofMalignant Gastric Outlet Obstruction in Advanced Gastric Cancer: A Multicenter Randomized Controlled Trial
Oct 7, 2026
Show all 2 updates
  1. Oct 15, 2026
    Secondary outcomes 2 added
    What changed in the outcomes
    • AddedTime to postoperative gastrointestinal functional recoveryTime frame: Within 30 days after surgery
    • AddedInitiation of subsequent systemic therapyTime frame: Within 12 months after surgery
    + 2 other changes: description and conditions
  2. Oct 7, 2026
    Recruiting→Not yet recruiting
    Publications Results publication added: Conventional Versus Stomach-Partitioning Gastrojejunostomy for Malignant Gastric Outlet Obstruction in Stage IV Gastric Cancer (GO-PART Study, KLASS 16)
    2 sites added
    Show 2 added (2 China)
    • Wuzhou Red Cross Hospital · Wuzhou, China
    • Wuming Hospital of Guangxi Medical University · Nanning, China
    Primary completion Jan 1, 2028→Jan 31, 2029
    Study completion Jan 1, 2029→Mar 31, 2029
    Eligibility 7 inclusion criteria added, 3 removed; 7 exclusion criteria edited, 3 added, 2 removed
    What changed in the criteria
    Inclusion criteria
    • Removed1.Patients and their families were fully aware of this study and voluntarily signed informed consent ; 2.Age 18-75 years old ( including 18 and 75 years old ) ; 3.Distal gastric cancer ( cT4bN + M0 / T3-4N + M1, stage IV ) with locally unresectable, distant metastasis or peritoneal metastasis confirmed by pathology and unable to undergo radical surgery ; 4.Complicated with digestive tract obstruction ( gastric retention confirmed by upper gastrointestinal radiography or gastroscopy, and GOOSS score ≤ 1 ) ; the ECOG score was 0-2 points, and there was no deterioration within 7 days ; 6.ASA score I-III ; 7.No previous anti-tumor therapy ( such as radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc. ) :
    • RemovedThe functions of important organs meet the following requirements :
    • Removedabsolute neutrophil count ≥ 1.5 × 109 / L, white blood cell count ≥ 4.0 × 109/L; (b) Platelet ≥ 100 × 109 / L ; (c) Hemoglobin ≥ 60g / L ; (d) TBIL ≤ 1.5 times ULN ; (e) ALT and AST ≤ 2.5 times ULN ; (f) urea / urea nitrogen ( BUN ) and creatinine ( Cr ) ≤ 1.5 × ULN ( and creatinine clearance rate ( CCr ) ≥ 50mL / min ) ; (g) Left ventricular ejection fraction ( LVEF ) ≥ 50 % ; the corrected QT interval ( QTcF ) by Fridericia method was less than 470 ms. (i) INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN. 9. women of childbearing age need to take effective contraceptive measures ; 10.No other surgical contraindications ; 11.good compliance, with follow-up.
    • AddedPatients and their family members must be fully informed of the study procedures and voluntarily provide written informed consent prior to enrollment.
    • AddedAge 18-75 years (inclusive).
    • AddedPathologically confirmed distal gastric adenocarcinoma deemed unresectable due to locally advanced disease, distant metastasis, or peritoneal dissemination (cT4bM0 or T3-4M1, regardless of the clinical lymph node status, stage IV), and therefore unsuitable for curative resection.
    • AddedPresence of gastrointestinal obstruction confirmed by upper gastrointestinal contrast radiography or endoscopy, manifested as gastric retention with a Gastric Outlet Obstruction Scoring System (GOOSS) score <= 1.
    • AddedEastern Cooperative Oncology Group (ECOG) performance status of 0-2 without deterioration within 7 days prior to enrollment.
    • AddedAmerican Society of Anesthesiologists (ASA) physical status classification I-III.
    • AddedNo prior antitumor therapy, including radiotherapy, chemotherapy, targeted therapy, or immunotherapy.
    Exclusion criteria
    • RemovedUnable to comply with the research program or research procedures ;
    • AddedInability or unwillingness to comply with the study protocol or required study procedures.
    • EditedPatients with other malignant tumorsHistory of another malignancy within 5 years beforeprior to enrollment, except forwith the exception of adequately treated basal cell carcinoma or squamous cell carcinoma of the skin after radical resection, or cervical carcinoma in situ ;of the cervix following curative therapy.
    • ChangedBefore Patients with active autoimmune diseases or a history of autoimmune diseases within 4 weeks before enrollment ;Now Active autoimmune disease within 4 weeks prior to enrollment or a documented history of autoimmune disease.
    • EditedPreviously receivedPrior allogeneic bone marrow transplantation or solid organ transplantation ;.
    • EditedCardiovascular diseases withClinically significant clinical significancecardiovascular disease, including but not limited to: acute myocardial infarction, severe /or unstable angina pectoris, or coronary artery bypass grafting within 6 months beforeprior to enrollment ; congestive heart failure classified as New York Heart Association ( NYHA ) gradefunctional class > 2 II; ventricular arrhythmiaarrhythmias requiring drugpharmacologic treatment ; lVEF (or left ventricular ejection fraction (LVEF) < 50 % ;.
    • ChangedBefore Active or uncontrolled severe infection ( ≥ CTCAE V5.0 grade 2 infection ) ;Now Active or uncontrolled severe infection, defined as grade >= 2 according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
    • EditedKnown human immunodeficiency virus ( HIV ) infection. Patients with known clinical, or a history of clinically significant liver disease, including viral hepatitis [: known as hepatitis B virus ( HBV ) carriers must be excluded fromif active HBV infection is present, that is,defined as HBV DNA positivepositivity ( > 1 × 104x 10\^4 copies / mL or > 2000 IU / ml mL) ; it is known that hepatitis C virus (HCV) infection ( HCV ) andwith positive HCV RNA positive ( > 1 × 103x 10\^3 copies / mL ) ;.
    • EditedpregnantPregnant women (positive pregnancy test positive before medication prior to treatment initiation) or breastfeedinglactating women ;.
    • RemovedAny other disease with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of the researchers, it is reasonable to suspect that the patient has a state that is not suitable for enrollment ( such as having seizures and requiring treatment ), or will affect the interpretation of the results of the study, or put the patient at high risk ; the researchers considered that the patients were not suitable for inclusion in this study.
    • AddedAny other disease, clinically significant metabolic disorder, abnormal physical examination finding, or laboratory abnormality that, in the judgment of the investigator, may render the patient unsuitable for study participation (e.g., uncontrolled seizure disorder requiring treatment), interfere with the interpretation of study results, or place the patient at undue risk.
    • AddedAny condition that, in the opinion of the investigator, makes the patient inappropriate for inclusion in this trial.
    Primary outcomes 1 time frame changed, 1 description edited
    What changed in the outcomes
    • Time frameIncidence of delayed gastric emptying(DGE)Evaluation time of delayed gastric emptying : day 3, day 7, day 14, day 21.after operation. → Within 30 days after surgery
    • DescriptionIncidence of delayed gastric emptying(DGE): how it is measured was reworded
    Secondary outcomes 2 edited, 5 added, 6 removed
    What changed in the outcomes
    • EditedpostoperativePostoperative mortalityTime frame: Within 90 days after surgery → 30 days and 90 days after surgery
    • EditedOverall survival ( OS )Time frame: Approximately weeks 1 - 2 after surgery → Up to 12 months after surgery
    • AddedIncidence of early postoperative complicationsTime frame: Within 30 days after surgery
    • AddedNutritional statusTime frame: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy
    • AddedIncidence of late postoperative complicationsTime frame: From 30 days to 12 months after surgery
    • AddedIncidence of anastomotic complicationsTime frame: Within 12 months after surgery
    • AddedHealth-related quality of lifeTime frame: Baseline; 1, 2 and 4 weeks after surgery; before first postoperative systemic therapy
    • RemovedPG-SGA scoreTime frame: Approximately 30 days
    • RemovedEarly postoperative complication rateTime frame: Within 21 days after surgery
    • RemovedLate postoperative complication rateTime frame: 21 days after operation
    • RemovedAnastomotic complication rateTime frame: Within 21 days after surgery
    • RemovedLife quality evaluation (QLQ-c30)Time frame: Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
    • Removedother outcomequality of life (QLQ-STO22)Time frame: Before operation and 1 week, 2 weeks, 4 weeks after operation and before the first systematic treatment after operation.
    Interventions Arm changed stomach-partitioning gastrojejunostomy→stomach-partitioning gastrojejunostomy (SPGJ); conventional gastrojejunostomy→conventional gastrojejunostomy (CGJ)
    Title Comparison of Partial Stomach-Partitioning andVersus Conventional Gastrojejunostomy for the Treatment ofMalignant Gastric Outlet Obstruction in Advanced Gastric Cancer: A Multicenter Randomized Controlled Trial
    + 6 other changes: index terms, responsible party, description, conditions, design details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07561073
Lead sponsor
Guangxi Medical University
Responsible party
Wu Liucheng (Clinical Professor, Cancer Hospital of Guangxi Medical University) — Principal investigator
First posted
May 1, 2026
Start date
Oct 20, 2026 (estimated)
Primary completion
Jan 31, 2029 (estimated)
Completion
Mar 31, 2029 (estimated)
Last update
Oct 15, 2026

Study contacts

Yuzhou Qin
Contact
qyz402@126.com
+867715310421
Liucheng Wu
Contact
wuliucheng@gxmu.edu.cn
13737146973

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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