Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
NCT ID: NCT05986890
Last Updated: 2025-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
16 participants
INTERVENTIONAL
2023-08-17
2026-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Roux-en-Y Bypass
laparoscopic Roux-en-Y
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.
gastrojejunostomy
surgical gastrojejunostomy
Interventions
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Roux-en-Y Bypass
laparoscopic Roux-en-Y
gastrojejunostomy
surgical gastrojejunostomy
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Spectrum Health Hospitals
OTHER
Responsible Party
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Gerald P. Wright
Surgical Oncology and Hepatopancreaticobiliary Surgeon
Principal Investigators
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G. Paul Wright, MD
Role: PRINCIPAL_INVESTIGATOR
Corewell Health
Locations
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G. Paul Wright
Grand Rapids, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2022-433
Identifier Type: -
Identifier Source: org_study_id
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