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Trial Title:
Roux-en-Y Gastric Bypass Versus Loop Gastrojejunostomy for Malignant Gastric Outlet Obstruction
NCT ID:
NCT05986890
Condition:
Malignant Gastric Outlet Obstruction
Conditions: Official terms:
Gastric Outlet Obstruction
Pyloric Stenosis
Conditions: Keywords:
MGOO
Malignant gastric outlet obstruction
gastric outlet
malignant tumor
proximal bowel obstruction
bowel obstruction
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Roux-en-Y Bypass
Description:
laparoscopic Roux-en-Y
Arm group label:
Roux-en-Y Bypass
Intervention type:
Procedure
Intervention name:
gastrojejunostomy
Description:
surgical gastrojejunostomy
Arm group label:
Gastrojejunostomy
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
G. Paul Wright
Address:
City:
Grand Rapids
Zip:
49503
Country:
United States
Status:
Recruiting
Contact:
Last name:
G. Paul M Wright, MD
Phone:
616-486-6333
Email:
paul.wright@corewellhealth.org
Contact backup:
Last name:
Esther L Peariso, MSN
Phone:
616-486-0358
Email:
esther.peariso@corewellhealth.org
Start date:
August 17, 2023
Completion date:
December 1, 2026
Lead sponsor:
Agency:
Spectrum Health Hospitals
Agency class:
Other
Source:
Spectrum Health Hospitals
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05986890
