Comparing endoscopic and surgical methods for treating gastric outlet obstruction
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
This study is testing whether a less invasive endoscopic procedure or a traditional surgery works better for treating gastric outlet obstruction caused by cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 3 sites (Manhasset, New York and 2 other locations) |
| Trial ID | NCT05561907 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two different procedures, endoscopic gastrojejunostomy (EGJ) and surgical gastrojejunostomy (SGJ), for treating gastric outlet obstruction (GOO) caused by periampullary malignancies. Patients will be randomly assigned to one of the two treatment groups after providing informed consent. Quality of life will be assessed through questionnaires at various time points before and after the procedures to evaluate their impact on symptoms and overall well-being. The study aims to collect data on adverse events and patient outcomes to determine the best approach for managing GOO.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with periampullary malignancies and symptoms of gastric outlet obstruction.
Not a fit: Patients under 18, pregnant individuals, or those with other gastrointestinal complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life and nutritional intake for patients suffering from gastric outlet obstruction.
How similar studies have performed: Other studies have shown promising results with similar endoscopic approaches, but this specific comparison of EGJ and SGJ is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Manhasset, New York and 2 other locations
- North Shore University Hospital — Manhasset, New York, United States (Recruiting)
- Long Island Jewish Medical Center — New Hyde Park, New York, United States (Recruiting)
- Lenox Hill Hospital — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Petros Benias, MD — Northwell Health
- Study coordinator: Molly Stewart
- Email: mstewart8@northwell.edu
- Phone: 718-470-4667
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.