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

Not Applicable

Recruiting

• Conditions: Malignant Gastric Outlet Obstruction
• Interventions: Procedure: Roux-en-Y Bypass; Procedure: gastrojejunostomy

• Registration Number: NCT05986890
• Lead Sponsor: Spectrum Health Hospitals

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-08-03
• Study First Submitted QC: 2023-08-03
• Study First Posted: 2023-08-14
• Study Start: 2023-08-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-05
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

1. Provision of signed and dated informed consent form.

2. Stated willingness to comply with all study procedures and availability for the duration of the study.

3. Male or female aged ≥18 years old.

4. Patients with a diagnosis of malignant gastric outlet obstruction. i. Defined as malignant cancer growth of any organ origin in the area of the distal stomach or duodenum preventing normal gastric emptying as determined by symptoms and cross-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 the distal stomach or duodenum, gastric distention, fluid filled stomach and decompressed bowel distal to obstruction point.

5. Patients deemed to benefit from surgical bypass as opposed to stent placement, by the primary surgeon. This includes assessing participants survival chances and ability to undergo a surgical procedure.

6. Patients in a general health status that permits abdominal surgery under general anesthesia. As determined by primary surgeon and anesthesiologist.

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Exclusion Criteria

1. Patients that have had previous treatment for malignant gastric outlet obstruction.

   a. Including any previous surgery or stent placement for MGOO

2. Patients with MGOO deemed to benefit more from endoscopic stent placement rather than surgery for symptom relief. This assessment will be at treating surgeon's discretion.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Roux-en-Y Bypass	Roux-en-Y Bypass	laparoscopic Roux-en-Y (R-Y) procedure is a well-established procedure, commonly utilized in the setting of bariatric- and gastric cancer surgery. The procedure establishes intestinal continuity that bypasses the distal stomach and duodenum. This is achieved by dividing the jejunum 30-40 cm distal to the ligament of Treitz, bringing the distal end of jejunum up anterior to the transverse colon to be anastomosed to the back wall of the stomach (forming the Roux-limb). The proximal cut end of jejunum then gets anastomosed to the downstream roux-limb (forming the Y-limb). The benefits of this reconstruction include less chance of gastric contents travelling into the afferent limb and similarly, avoiding bile reflux from the afferent limb with associated bile gastritis.
Gastrojejunostomy	gastrojejunostomy	surgical gastrojejunostomy, a procedure dating back to the late 1800's.5 This surgical bypass consists of connecting the stomach to a loop of proximal small bowel, thus bypassing any duodenal or distal gastric obstruction.

Primary Outcome Measures

Name	Time	Method
Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.	7 days post operative	Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients

Secondary Outcome Measures

Name	Time	Method
Patient reported daily gastric outlet obstruction scoring system (GOOS) score	30 days postoperative	Patients will score each day with the score that reflects the diet that was tolerated that day by the patient. This includes what was able to be ingested without a subsequent vomiting.
Time from surgery to death	100 days postoperative
Improvement of quality of life as measured GIQLI	measured pre-operatively, at 25-35 days post op and 80-100 days post op	The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
Number of patients requiring reoperation for any indication	30 days postoperative
Improvement of quality of life as measured by short form QOL Questionnaire	measured pre-operatively, at 25-35 days post op and 80-100 days post op	The short form 36 question QOL questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
Gastric emptying study at 30-days	30 days post operative	Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Number of Clavien-Dindo grade ≥3 adverse event	14 days postoperative
number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery	30 days postoperative

Trial Locations

Locations (1)

G. Paul Wright; 🇺🇸 Grand Rapids, Michigan, United States