Gastric Bypass vs Gastrojejunostomy for Gastric Outlet Obstruction

N/A

Recruiting

Led By G. Paul Wright, MD

Research Sponsored by Spectrum Health Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured pre-operatively, at 25-35 days post op and 80-100 days post op

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two types of stomach surgery to see which one will help patients with stomach blockage eat solid food better.

Who is the study for?

This trial is for adults (≥18 years) with malignant gastric outlet obstruction, which causes symptoms like abdominal pain and vomiting. Participants must be able to undergo surgery under general anesthesia and have not had previous treatments for this condition. They should consent to study procedures and be available throughout the study.

What is being tested?

The study compares two surgeries: Roux-en-Y Gastric Bypass versus Loop Gastrojejunostomy, to see which one is better at improving solid food intake within the first month after surgery in patients with malignant gastric outlet obstruction.

What are the potential side effects?

Potential side effects of these surgeries may include infection, bleeding, reaction to anesthesia, nutritional deficiencies due to altered digestion, leakage from surgical connections between intestines or stomach.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured pre-operatively, at 25-35 days post op and 80-100 days post op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured pre-operatively, at 25-35 days post op and 80-100 days post op

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured pre-operatively, at 25-35 days post op and 80-100 days post op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.

Secondary study objectives

Gastric emptying study at 30-days

Improvement of quality of life as measured GIQLI

Improvement of quality of life as measured by short form QOL Questionnaire

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Roux-en-Y BypassExperimental Treatment1 Intervention

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.

Group II: GastrojejunostomyExperimental Treatment1 Intervention

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.

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