RecruitingNot ApplicableNCT06128018
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction
Sponsor
AdventHealth
Enrollment
70 participants
Start Date
Nov 1, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- ≥ 18 years of age.
- Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
- GOOSS of 0 or 1
- BOTH surgical and endoscopic GJ are technically and clinically feasible
- Can understand and is willing to sign informed consent form prior to the initiation of any study procedures (or when applicable the subject's LAR).
Exclusion Criteria8
- < 18 years of age
- ECOG >2
- Expected survival (determined by the treating oncologist) is less than 2 months.
- Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
- Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
- Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
- Anatomical factors that technically hinder EUS-GJ OR Surgical-GJ (diffuse tumor involvement in path of LAMS or surgery, surgically altered anatomy that interferes with the ability to perform an anastomosis etc)
- Pregnancy
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Interventions
PROCEDURESurgical gastrojejunostomy (S-GJ)
Surgical gastro-jejunostomy
PROCEDUREEUS-guided gastrojejunostomy (EUS-GJ)
Endoscopic Ultrasound guided gastro-jejunostomy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06128018