An interventional study of Conventional Gastrojejunostomy and Stomach-Partitioning in Stomach Neoplasms and Gastric Outlet Obstruction, sponsored by Gyeongsang National University Hospital. Recruiting at 1 site in South Korea. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-11.
Sponsored by Gyeongsang National University Hospital · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to evaluate whether stomach-partitioning gastrojejunostomy (SPGJ) more effectively reduces postoperative delayed gastric emptying (DGE) compared to conventional gastrojejunostomy (CGJ) in patients with unresectable stage IV gastric cancer accompanied by malignant gastric outlet obstruction (MGOO). This multicenter randomized trial aims to establish a new surgical standard that enhances recovery and quality of life in advanced gastric cancer.
The main questions are:
Participants Eligible participants are adults aged 20-85 years with histologically proven unresectable gastric adenocarcinoma limited to the lower third of the stomach and endoscopic or radiologic evidence of obstruction. Patients with total bowel obstruction, middle-third tumor extension, emergency conditions, or severe malnutrition (albumin \< 2.5 g/L) are excluded.
Interventions
All operations follow standardized training videos and pretrial workshops to ensure consistency across 32 Korean university hospitals.
Study Design This is a prospective, randomized controlled multicenter trial (KLASS 16). After intraoperative diagnostic laparoscopy confirms eligibility, participants are randomized by a secure web-based block system stratified by hospital. A total of 144 patients (72 per arm) will be enrolled, ensuring 90% statistical power based on expected DGE rates (CGJ 34.6% vs SPGJ 3.8%).
Endpoints
Data Collection and Analysis Data will include postoperative nutrition recovery, complication grades, and survival follow-up. Analyses will utilize Chi square or Fisher's exact test for DGE rates and Kaplan-Meier with log rank testing for survival. Logistic regression will identify DGE risk factors.
Duration Total 3 years: 6 months preparation, 1 year enrollment, 1 year follow up, and 6 months for data analysis and reporting.
Expected Outcomes SPGJ is expected to reduce DGE by > 70%, shorten hospital stay by \~3 days, and enable earlier chemotherapy, thereby improving palliative care outcomes and overall patient quality of life. The KLASS 16 trial will provide the first multicenter, Level I evidence to determine whether SPGJ should replace CGJ as the standard palliative procedure for MGOO.
3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.
This study's planned enrollment of 144 is above the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Gyeongsang National University Hospital is the lead sponsor of 21 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
confirmed gastric adenocarcinoma with Gastric Outlet Obstruction (GOO) that is unresectable for cure (e.g., surrounding tissue invasion, localized peritoneal , distant metastasis)
Tumor location confined to the lower one-third (Low body 1/3) of the stomach ③ Age between 20 and 85 years
Exclusion Criteria:
Patients with bowel obstruction due to extensive peritoneal (P3)
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.
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.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Conventional Gastrojejunostomy group
Procedure: Conventional Gastrojejunostomy
Stomach-Partitioning Gastrojejunostomy group
Procedure: Conventional Gastrojejunostomy · Procedure: Stomach-Partitioning
Traditional Laparoscopic Gastrojejunostomy
Laparoscopic stomach partitioning (Transversely divide the stomach 5 cm or more proximal to the tumor mass, leaving an approximately 2 cm uncut space at the lesser curvature (LC) side)
Comparison of the Incidence of Delayed Gastric Emptying (DGE)
DGE occurring within 30 days post-surgery between the Conventional Gastrojejunostomy (CGJ) group and the Stomach-Partitioning Gastrojejunostomy (SPGJ) group
Time frame: 30 days post-surgery
Gastric Outlet Obstruction Score at Postoperative Day 7.
0: No oral intake (unable to eat or drink anything), 1: Liquids only, 2: Soft foods/half fluids only, 3: Almost normal diet, 4: Normal diet
Time frame: Postoperative Day 7.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Sharing will commence no later than 6 months after the publication of the primary manuscript in an ICMJE-member journal. The data will remain accessible for a minimum period of 5 years from the start date, with a possibility for extension upon re-evaluation by the study team
Access criteria: Access will be granted to all researchers submitting a scientifically and methodologically sound proposal for secondary research. Materials provided will include: De-identified Individual Participant Data (IPD), the Study Protocol, the Statistical Analysis Plan (SAP), the Data Dictionary, and the Analytic Code used for the primary publication. Access Mechanism: Researchers must submit a formal proposal, proof of Institutional Review Board (IRB) approval, and sign a Data Use Agreement (DUA) to the KLASS 16 Central Study Team (Principal Investigator). Data access will be provided via a secure, controlled-access platform following approval. The requestor may be subject to a nominal data transfer fee.
Data sharing details ↗ · klass.or.kr
Started Aug 2026 (actual). Primary completion is estimated for Jul 2028, 23 months after the start.
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 23 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.
How these figures are worked out, and which studies are left out of them.
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Gyeongsang National University Hospital