RECRUITINGINTERVENTIONAL
Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Provision of signed and dated willing to sign a consent form 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.
Who Should NOT Join This Trial:
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.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
PROCEDURE
Roux-en-Y Bypass
laparoscopic Roux-en-Y
PROCEDURE
gastrojejunostomy
surgical gastrojejunostomy
Locations (1)
G. Paul Wright
Grand Rapids, Michigan, United States