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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Malignant Gastric Outlet Obstruction

Intervention / Treatment
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* Procedure: Roux-en-Y Bypass
* Procedure: gastrojejunostomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent form. Stated willingness to comply with all study procedures and availability for the duration of the study. Male or female aged ≥18 years old. 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. 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. Patients in a general health status that permits abdominal surgery under general anesthesia. As determined by primary surgeon and anesthesiologist. 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 rather than surgery for symptom relief. This assessment will be at treating surgeon's discretion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Roux-en-Y Bypass<br>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. | Procedure: Roux-en-Y Bypass<br>* laparoscopic Roux-en-Y<br>|
| Other: Gastrojejunostomy<br>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. | Procedure: gastrojejunostomy<br>* surgical gastrojejunostomy<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gastric emptying study at 30-days | Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients | 30 days post operative | 
| Patient reported daily gastric outlet obstruction scoring system (GOOS) score | 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. | 30 days postoperative | 
| Number of Clavien-Dindo grade ≥3 adverse event |  | 14 days postoperative | 
| Number of patients requiring reoperation for any indication |  | 30 days postoperative | 
| number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery |  | 30 days postoperative | 
| Time from surgery to death |  | 100 days postoperative | 
| Improvement of quality of life as measured by short form QOL Questionnaire | 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 | measured pre-operatively, at 25-35 days post op and 80-100 days post op | 
| Improvement of quality of life as measured GIQLI | The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life | measured pre-operatively, at 25-35 days post op and 80-100 days post op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MGOO, Malignant gastric outlet obstruction, gastric outlet, malignant tumor, proximal bowel obstruction, bowel obstruction