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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients that have had previous treatment for malignant gastric outlet obstruction.
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.
Trial design
Parallel
Treatments tested in this trial
Roux-en-Y Bypass
Procedure/Surgerylaparoscopic Roux-en-Y
gastrojejunostomy
Procedure/Surgerysurgical gastrojejunostomy
Treatment groups
Trial outcomes
Primary outcomes
Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Secondary outcomes
Gastric emptying study at 30-days
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Patient reported daily gastric outlet obstruction scoring system (GOOS) score
Patients will score each day with the score that reflects the diet that was tolerated that day by the patient. This includes what was able to be ingested without a subsequent vomiting.
Number of Clavien-Dindo grade ≥3 adverse event
Number of patients requiring reoperation for any indication
Sponsors and contacts
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