The role of endoscopy in gastroduodenal obstruction and gastroparesis.
ASGE Standards of Practice Committee, Norio Fukami, Michelle A Anderson...
https://pubmed.ncbi.nlm.nih.gov/21704805Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06128018
Randomized Trial Comparing Endoscopic Ultrasound-Guided and Surgical Gastrojejunostomy for Management of Malignant Gastric Outlet Obstruction
Led by AdventHealth · Updated on 2026-04-27
70
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating two treatment options for malignant gastric outlet obstruction, a blockage in the stomach or duodenum caused by cancer. This study aims to compare the safety and adverse event rates between Endoscopic Ultrasound-guided gastrojejunostomy (EUS-GJ) and Surgical gastrojejunostomy (S-GJ). Participants will be randomly assigned to one of these procedures and followed to evaluate outcomes. The study involves two procedures: EUS-GJ, which uses endoscopic ultrasound to create a bypass, and S-GJ, a surgical method to connect the stomach to the jejunum. Both procedures are considered standard treatments and must be feasible for each participant. Participants will be monitored for up to 12 months after their assigned procedure to collect relevant safety and effectiveness data. Throughout the study, participants will be assessed for procedure-related adverse events and overall outcomes. The primary outcome focuses on identifying the safety profile of EUS-GJ over a 24-month period. Participants will undergo clinical evaluations and follow-up to ensure comprehensive data collection on treatment effects and safety.
CONDITIONS
Official Title
Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Radiographic or endoscopic evidence of an obstructing tumor in the distal stomach or duodenum
- Gastric Outlet Obstruction Scoring System (GOOSS) score of 0 or 1
- Both surgical and endoscopic gastrojejunostomy are technically and clinically possible
- Ability to understand and sign the informed consent form or have a legally authorized representative do so
You will not qualify if you...
- Younger than 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status greater than 2
- Expected survival less than 2 months as determined by the treating oncologist
- Candidates for potential cancer resection including borderline resectable pancreatic cancer
- Peritoneal carcinomatosis with bowel obstruction seen on imaging or laparoscopy
- Large volume ascites (moderate volume ascites patients may undergo drainage before randomization)
- Anatomical issues that prevent EUS-GJ or surgical gastrojejunostomy (e.g., diffuse tumor involvement, surgically altered anatomy)
- Pregnancy
AI-Screening
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1
2
3
Trial Site Locations
Total: 1 location
1
AdventHealth Orlando
Orlando, Florida, United States, 32804
Actively Recruiting
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Research Team
D
Diana Paredes
P
Petronio Martins
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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Published Research Related To This Trial
Morbidity-associated factors after gastrojejunostomy for malignant gastric outlet obstruction.
Heriberto Medina-Franco, Leonardo Abarca-Pérez, Nayví España-Gómez...
https://pubmed.ncbi.nlm.nih.gov/17939415Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients.
Douglas G Adler, Todd H Baron
https://pubmed.ncbi.nlm.nih.gov/11808972EUS-guided gastrojejunostomy after failed enteral stenting.
Amy Tyberg, Nikhil Kumta, Kunal Karia...
https://pubmed.ncbi.nlm.nih.gov/25680897EUS-guided gastrojejunostomy for management of complete gastric outlet obstruction.
Mouen A Khashab, Alan H Tieu, Alba Azola...
https://pubmed.ncbi.nlm.nih.gov/26092615Current status and perspective of endoscopic ultrasonography-guided gastrojejunostomy: endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy (with videos).
Takao Itoi, Kentaro Ishii, Reina Tanaka...
https://pubmed.ncbi.nlm.nih.gov/25155270Prospective evaluation of endoscopic ultrasonography-guided double-balloon-occluded gastrojejunostomy bypass (EPASS) for malignant gastric outlet obstruction.
Takao Itoi, Kentaro Ishii, Nobuhito Ikeuchi...
https://pubmed.ncbi.nlm.nih.gov/26282674Endoscopic ultrasound-guided gastroenterostomy using novel tools designed for transluminal therapy: a porcine study.
K F Binmoeller, J N Shah
https://pubmed.ncbi.nlm.nih.gov/22531985Natural orifice transluminal endoscopic surgery gastroenterostomy with a biflanged lumen-apposing stent: first clinical experience (with videos).
Marc Barthet, Kenneth F Binmoeller, Geoffroy Vanbiervliet...
https://pubmed.ncbi.nlm.nih.gov/25527056Novel EUS-guided gastrojejunostomy technique using a new double-balloon enteric tube and lumen-apposing metal stent (with videos).
Takao Itoi, Fumihide Itokawa, Toshio Uraoka...
https://pubmed.ncbi.nlm.nih.gov/24237949