Clinical trial NCT05986890: Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
Official title: Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Gastric Outlet Obstruction
Keywords: MGOO
Malignant gastric outlet obstruction
gastric outlet
malignant tumor
proximal bowel obstruction
bowel obstruction
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Gastric emptying as per gastric emptying scintigraphy at 7 days post-operatively.
timeFrame: 7 days post operative
Secondary outcomes:
measure: Gastric emptying study at 30-days
timeFrame: 30 days post operative
measure: Patient reported daily gastric outlet obstruction scoring system (GOOS) score
timeFrame: 30 days postoperative
measure: Number of Clavien-Dindo grade ≥3 adverse event
timeFrame: 14 days postoperative
measure: Number of patients requiring reoperation for any indication
timeFrame: 30 days postoperative
measure: number of patients with diagnoses of delayed gastric emptying defined as per the International Study Group of Pancreatic Surgery
timeFrame: 30 days postoperative
measure: Time from surgery to death
timeFrame: 100 days postoperative
measure: Improvement of quality of life as measured by short form QOL Questionnaire
timeFrame: measured pre-operatively, at 25-35 days post op and 80-100 days post op
measure: Improvement of quality of life as measured GIQLI
timeFrame: measured pre-operatively, at 25-35 days post op and 80-100 days post op
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: G. Paul Wright
state: Michigan
Study officials:
affiliation: Corewell Health
name: G. Paul Wright, MD
role: PRINCIPAL_INVESTIGATOR
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