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

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Corewell Health West
Study ID
NCT05986890
Status
Recruiting
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Conditions

  • Malignant Gastric Outlet Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roux-en-Y Bypass — PROCEDURE
    laparoscopic Roux-en-Y
  • gastrojejunostomy — PROCEDURE
    surgical gastrojejunostomy

Study Details

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.

Key Dates

Start date
Aug 17, 2023
Status verified
Jun 2025
Primary completion
Dec 1, 2025
Completion
Dec 1, 2026

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: 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.
  • Other: 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.

Primary Outcome Measure

Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively. [ Time Frame: 7 days post operative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
G. Paul WrightGrand RapidsMichigan49503
G. Paul M Wright, MD
[email protected]
6164866333
Cindy Cheung, BS
[email protected]
6164860990

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