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.
Malignant gastric outlet obstruction is when malignant tumor growth obstructs the gastric outlet at the level of the distal stomach or duodenum, causing food intolerance with nausea and vomiting. Most often, this signifies advanced neoplastic disease with associated poor prognosis for patients. Restoring patients to oral intake is important for palliative purposes. The current standard of care in patients requiring long-term alleviation of symptoms (≥2 months) is performing a loop gastrojejunostomy. This involves creating an intestinal bypass to the site of obstruction in the duodenum or distal stomach. This procedure has long been criticized for its poor resultant function for patients, mainly due to poor tolerance to food intake that include frequent episodes of nausea and vomiting and inability to for solid food intake. The need for a durable solution to malignant gastric outlet obstruction that provides better tolerance to solid food intake is evident. The roux-en-y gastric bypass procedure has been performed for a variety of indications for decades, most commonly for weight loss but also with oncologic resections of the stomach in cases of gastric cancer. Laparoscopic roux-en-y gastric bypass (R-Y bypass) has become the standard for this procedure in experienced hands and has been found to be safe in the short- and long term. The long-term function after R-Y bypass is generally favorable across published literature. No studies exist to compare loop gastrojejunostomy to roux-en-y gastric bypass in patients with malignant gastric outlet obstruction.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
laparoscopic Roux-en-Y
surgical gastrojejunostomy
G. Paul Wright
Grand Rapids, Michigan, United States
RECRUITINGGastric 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
Time frame: 7 days post operative
Gastric emptying study at 30-days
Results of this study are given as percentage gastric emptying of radioactive (99mTc-SC) nutrients
Time frame: 30 days post operative
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.
Time frame: 30 days postoperative
Number of Clavien-Dindo grade ≥3 adverse event
Time frame: 14 days postoperative
Number of patients requiring reoperation for any indication
Time frame: 30 days postoperative
number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery
Time frame: 30 days postoperative
Time from surgery to death
Time frame: 100 days postoperative
Improvement of quality of life as measured by short form QOL Questionnaire
The short form 36 question QOL questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
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Time frame: measured pre-operatively, at 25-35 days post op and 80-100 days post op
Improvement of quality of life as measured GIQLI
The Gastrointestinal quality of life questionnaire results in a cumulative score with an increase in score representing a better health-related quality of life
Time frame: measured pre-operatively, at 25-35 days post op and 80-100 days post op