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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 intake. We hypothesize that roux-en-y bypass will be associated with improved solid food intake in the first 30 days after surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
United States
Michigan
G. Paul Wright
RECRUITING
Grand Rapids
Contact Information
Primary
G. Paul Wright, MD
paul.wright@corewellhealth.org
616-486-6333
Backup
Cindy Cheung, BS
cindy.cheung@corewellhealth.org
6164860990
Time Frame
Start Date: 2023-08-17
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 16
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Spectrum Health Hospitals

This content was sourced from clinicaltrials.gov

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