Comparing two surgical methods for treating malignant gastric outlet obstruction
Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
This study is testing whether roux-en-y gastric bypass surgery helps people with malignant gastric outlet obstruction eat solid food better in the first month after surgery compared to a traditional method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Corewell Health West Academic / other |
| Locations | 1 site (Grand Rapids, Michigan) |
| Trial ID | NCT05986890 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of roux-en-y gastric bypass surgery compared to conventional loop gastrojejunostomy for patients suffering from malignant gastric outlet obstruction. The primary focus is on the tolerance to solid food intake within the first 30 days post-surgery. Malignant gastric outlet obstruction is a serious condition often associated with advanced cancer, leading to significant food intolerance and poor quality of life. The study aims to determine if the roux-en-y bypass can provide better outcomes in terms of food intake and overall patient comfort.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with malignant gastric outlet obstruction who are expected to benefit from surgical intervention.
Not a fit: Patients who are not candidates for surgical bypass or those with a prognosis that does not support surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved food tolerance and quality of life for patients with malignant gastric outlet obstruction.
How similar studies have performed: While no studies have directly compared these two surgical approaches, the roux-en-y gastric bypass has shown favorable long-term outcomes in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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. 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.
Where this trial is running
Grand Rapids, Michigan
- G. Paul Wright — Grand Rapids, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: G. Paul Wright, MD — Corewell Health
- Study coordinator: G. Paul Wright, MD
- Email: paul.wright@corewellhealth.org
- Phone: 616-486-6333
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.