An interventional study of Surgical gastrojejunostomy (SGJ) and Endoscopic gastrojejunostomy (EGJ) in Gastric Outlet Obstruction, sponsored by Northwell Health. Recruiting at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by Northwell Health · Not applicable, Interventional, and Treatment
Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment
After potential subjects are screened from the physicians' schedules, they will be assessed for further inclusion criteria. They will be presented with the informed consent form for their review. Once they have been given the opportunity to review and ask questions, they will sign the consent form and from this point will be considered enrolled into the study.
After signing the informed consent, subjects will be randomized to one of the two cohorts in a 1:1 manner.
On the day of their assigned procedures, subjects will be asked several quality of life questionnaires to obtain a baseline status.
Data will be collected during and immediately following the procedure to assess for any possible adverse events.
Follow-up data will be completed at the following timepoints: 1-day, 2-day, 3-day, 4-day, and 7-day, 30-day, 3-month, 6-month, and 1-year post-procedure.
QOL Scoring Systems GOOSS- Gastric Outlet Obstruction Symptom Score
GFS- Gut Function Score from Lowe et al 2002
Pre-Procedure Variables to Record Demographic
Clinical Parameters
Procedural Parameters
Post-procedure Hospitalization Daily Function
Post procedural AEs
30 Day Outcomes
38 studies on the registry are indexed under Gastric Outlet Obstruction; 14 are open to participants now.
This study's planned enrollment of 32 is below the median of 69 across 28 interventional studies indexed under Gastric Outlet Obstruction.
Browse Gastric Outlet Obstruction studies →Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.
Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.
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.
Symptoms of gastric outlet obstruction (at least 2 of 4 required):
Exclusion Criteria:
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.
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.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
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.
An anastomosis will be created between the stomach and the proximal loop of the jejunum during a laparoscopic surgical procedure.
Procedure: Surgical gastrojejunostomy (SGJ)
A stent is placed between the stomach and adjacent small intestine under endoscopic ultrasound guidance during an upper endoscopic procedure.
Procedure: Endoscopic gastrojejunostomy (EGJ)
Laparoscopic gastrojejunostomy
Endoscopic ultrasound (EUS) guided gastrojejunostomy
Time to initiation of solid oral intake without symptoms of GOO
Days to initiation of solid oral intake will be measured from randomization to first day of intake of soft solid foods, as indicated by a GOOSS score of 2
Time frame: 1 year
Safety of procedure
All adverse events (AEs) occurring after treatment will be graded according to ASGE lexicon. A subject will be considered to have had an adverse event if they had one or more adverse events, and they will be considered to have had a serious adverse event (SAE) if they had one or more serious adverse events
Time frame: 1 year
Technical success of procedure
Technical success is defined as adequate deployment and positioning of the stent(s) for EGJ or technical possibility to create an anastomosis for SGJ.
Time frame: 1 year
Clinical success of procedure
Clinical success is defined as improvement to a GOOSS score of 2 or 3 (oral intake of soft solid foods or resumption of full diet) without additional intervention.
Time frame: 1 year
Time to discharge
Length of stay will be measured from randomization to discharge alive. All patients will be followed until discharge. Patients who die in hospital will be considered censored and time from randomization to death will be used.
Time frame: 1 year
Change in BMI
BMI will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Time frame: 3 months
Change in albumin levels
Albumin levels will be measured immediately prior to the procedure, and at one month and three months after the procedure.
Time frame: 3 months
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
The Gastric Outlet Obstruction Symptom Score (GOOSS) scale is as follows, whereas a score of 1 is the worst and a score of 4 is the best: 1. Inadequate or no oral intake 2. Liquids/thickened liquids 3. Semisolids/ low residue 4. Unmodified GOOSS will be recorded at each of the following timepoints: * immediately prior to the procedure * immediately post-procedure * 1-day post-procedure * 2-days post-procedure * 3-days post-procedure * 4-days post-procedure * 7-days post-procedure, * 30-days post-procedure * 3-months post-procedure * 6-months post-procedure * 1-year post-procedure
Time frame: 1 year
Change in Gut Function Score (GFS)
Gut Function Score (GFS) scale is as follows, whereas a score of 1 is the worst and a score of 3 is the best: 0\. Profuse vomiting 1. Nausea and occasional vomiting 2. Nausea only 3. Normal gut function GFS will be recorded at each of the following timepoints: * Immediately prior to the procedure * Immediately post-procedure * 1-day post-procedure * 2-days post-procedure * 3-days post-procedure * 4-days post-procedure * 7-days post-procedure, * 30-days post-procedure * 3-months post-procedure * 6-months post-procedure * 1-year post-procedure
Time frame: 1 year
Karnofsky Performance Scale (KPS)
Karnofsky Performance Scale is measured on a scale of 0 to 100 as follows, with a score of 0 being the worst and a score of 100 being the best: 100 - Normal; no complaints; no evidence of disease. 90 - Able to carry on normal activity; minor signs or symptoms of disease. 80 - Normal activity with effort; some signs or symptoms of disease. 70 - Cares for self; unable to carry on normal activity or to do active work. 60 - Requires occasional assistance, but is able to care for most of their personal needs. 50 - Requires considerable assistance and frequent medical care. 40 - Disabled; requires special care and assistance. 30 - Severely disabled; hospital admission is indicated although death not imminent. 20 - Very sick; hospital admission necessary; active supportive treatment necessary. 10 - Moribund; fatal processes progressing rapidly. 0 - Dead KPS will be recorded pre-procedure and at 30-days post-procedure.
Time frame: 30 Days
Chemotherapeutic regimen tolerance
Ability to tolerate TB approved chemotherapeutic regimen
Time frame: 30 Days
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Plan to share: No
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