RecruitingInterventional

Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

NCT ID: NCT05561907Sponsor: Northwell HealthLast updated: 2026-06-15

Summary

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

Detailed description

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 * 1 Inadequate or no oral intake * 2 Liquids/thickened liquids * 3 Semisolids/ low residue * 4 unmodified GFS- Gut Function Score from Lowe et al 2002 * 0 Profuse vomiting * 1 Nausea and occasional vomiting * 2 Nausea only * 3 Normal gut function Pre-Procedure Variables to Record Demographic * Gender * Weight * BMI * Cancer Type Clinical Parameters * GOOSS * Gut Function Score * Karnofsky Performance Scale Procedural Parameters * EUS-GJ: presence of ascites, able to pass scope beyond obstruction, use of wire to stabilize position, Length of procedure, intraprocedural AEs, Stent size used, successful completion of procedure * Laparoscopic GJ: presence of ascites, length of procedure, intraprocedural AEs, conversion to open GJ, successful completion of procedure Post-procedure Hospitalization Daily Function * GOOSS * Gut Function Score * Time to initiation of oral intake liquids * Time to initiation of oral intake solids * Time to discharge * Post procedural AEs 30 Day Outcomes * GOOSS * Gut Function Score * Karnofsky Performance Scale * Weight/BMI * Able to tolerate TB approved chemotherapeutic regimen

Arms & interventions

ProcedureSurgical gastrojejunostomy (SGJ)
Laparoscopic gastrojejunostomy
ProcedureEndoscopic gastrojejunostomy (EGJ)
Endoscopic ultrasound (EUS) guided gastrojejunostomy

Outcome measures

Primary

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

Secondary

Safety of procedure
Time frame: 1 year
Technical success of procedure
Time frame: 1 year
Clinical success of procedure
Time frame: 1 year
Time to discharge
Time frame: 1 year
Change in BMI
Time frame: 3 months
Change in albumin levels
Time frame: 3 months
Change in Gastric Outlet Obstruction Symptom Score (GOOSS)
Time frame: 1 year
Change in Gut Function Score (GFS)
Time frame: 1 year
Karnofsky Performance Scale (KPS)
Time frame: 30 Days
Chemotherapeutic regimen tolerance
Time frame: 30 Days

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: 1. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer 2. Symptoms of gastric outlet obstruction (at least 2 of 4 required): 1. post prandial vomiting, 2. abdominal pain, 3. inability to tolerate PO, 4. imaging consistent with GOO 3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only) 4. Age \>18 years old 5. Life expectancy greater than 2 months or failed duodenal stenting 6. Surgical Candidate/Tolerate General Anesthesia 7. Unresectable or metastatic disease Exclusion Criteria: 1. Age\< 18 years old 2. Pregnancy 3. Intestinal obstruction distal to the Ligament of Treitz 4. Evidence of other luminal strictures of the GI tract 5. Previous gastric or periampullary surgery 6. Inability to complete quality of life surveys (QOLS) 7. Presence of abdominal ascites

Study locations (4)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901

Recruiting

Molly Stewart · Contact

(732) 235-3247 molly.stewart1@rutgers.edu

Petros Benias, MD · Principal Investigator

Arvind Trindade, MD · Sub Investigator

North Shore University Hospital

Manhasset, New York, 11030

Completed

Long Island Jewish Medical Center

New Hyde Park, New York, 11040

Completed

Lenox Hill Hospital

New York, New York, 10075

Completed

References

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