Status:
RECRUITING
Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
Lead Sponsor:
Corewell Health West
Conditions:
Malignant Gastric Outlet Obstruction
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT05986890
Start Date
August 17 2023
End Date
December 1 2026
Last Update
June 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
G. Paul Wright
Grand Rapids, Michigan, United States, 49503