Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction

Phase

N/A

Condition

Vomiting

Treatment

gastrojejunostomy

Roux-en-Y Bypass

Clinical Study ID

NCT05986890

2022-433

Ages > 18
All Genders

Study Summary

This study is intended to investigate whether roux-en-y bypass surgery is superior to conventional loop gastrojejunostomy for Malignant gastric outlet obstruction in terms of tolerance to solid food intake. We hypothesize that roux-en-y bypass will be associated with improved solid food intake in the first 30 days after surgery.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for theduration of the study.
Male or female aged ≥18 years old.
Patients with a diagnosis of malignant gastric outlet obstruction. i. Defined asmalignant cancer growth of any organ origin in the area of the distal stomach orduodenum preventing normal gastric emptying as determined by symptoms andcross-sectional imaging studies. ii. Symptoms can include abdominal distention, abdominal pain, nausea and vomiting. iii. Cross sectional imaging findings can include tumor growth in the area of thedistal stomach or duodenum, gastric distention, fluid filled stomach anddecompressed bowel distal to obstruction point.
Patients deemed to benefit from surgical bypass as opposed to stent placement, bythe primary surgeon. This includes assessing participants survival chances andability to undergo a surgical procedure.
Patients in a general health status that permits abdominal surgery under generalanesthesia. As determined by primary surgeon and anesthesiologist.

Exclusion

Exclusion Criteria:

Patients that have had previous treatment for malignant gastric outlet obstruction. a. Including any previous surgery or stent placement for MGOO
Patients with MGOO deemed to benefit more from endoscopic stent placement ratherthan surgery for symptom relief. This assessment will be at treating surgeon'sdiscretion.

Study Design

gastrojejunostomy

August 17, 2023

December 01, 2026

Study Description

Malignant gastric outlet obstruction is when malignant tumor growth obstructs the gastric outlet at the level of the distal stomach or duodenum, causing food intolerance with nausea and vomiting. Most often, this signifies advanced neoplastic disease with associated poor prognosis for patients. Restoring patients to oral intake is important for palliative purposes. The current standard of care in patients requiring long-term alleviation of symptoms (≥2 months) is performing a loop gastrojejunostomy. This involves creating an intestinal bypass to the site of obstruction in the duodenum or distal stomach. This procedure has long been criticized for its poor resultant function for patients, mainly due to poor tolerance to food intake that include frequent episodes of nausea and vomiting and inability to for solid food intake. The need for a durable solution to malignant gastric outlet obstruction that provides better tolerance to solid food intake is evident. The roux-en-y gastric bypass procedure has been performed for a variety of indications for decades, most commonly for weight loss but also with oncologic resections of the stomach in cases of gastric cancer. Laparoscopic roux-en-y gastric bypass (R-Y bypass) has become the standard for this procedure in experienced hands and has been found to be safe in the short- and long term. The long-term function after R-Y bypass is generally favorable across published literature. No studies exist to compare loop gastrojejunostomy to roux-en-y gastric bypass in patients with malignant gastric outlet obstruction.

Connect with a study center

G. Paul Wright
Grand Rapids, Michigan 49503
United States
Active - Recruiting

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