Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Not Applicable

Recruiting

• Conditions: Malignant Gastric Outlet Obstruction
• Interventions: Procedure: EUS-guided gastrojejunostomy (EUS-GJ); Procedure: Surgical gastrojejunostomy (S-GJ)

• Registration Number: NCT06128018
• Lead Sponsor: AdventHealth

Brief Summary

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction.

Detailed Description

The goal of this interventional study is to learn about the outcomes between two options for the management of malignant gastric outlet obstruction. The main question this study aims to answer is:

1. To compare the rates of procedure related adverse events (AE's) between patients undergoing Endoscopy Ultrasound-guided gastro-jejunostomy (EUS-GJ) and Surgical gastro-jejunostomy (S-GJ).

Study participants will be randomized into one of the two standard procedures and followed for up to 12 months post procedure for collection of outcomes related data

Study Timeline

• Study First Submitted: 2023-10-24
• Study Start: 2023-11-01
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-13
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-07
• Last Update Posted: 2024-03-08
• Primary Completion: 2025-12-01
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. ≥ 18 years of age.
2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
3. GOOSS of 0 or 1
4. BOTH surgical and endoscopic GJ are technically and clinically feasible
5. 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 Criteria

1. < 18 years of age
2. ECOG >2
3. Expected survival (determined by the treating oncologist) is less than 2 months.
4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
7. 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)
8. Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical gastrojejunostomy (S-GJ)	EUS-guided gastrojejunostomy (EUS-GJ)	Patients on this arm will undergo the surgical procedure.
EUS-guided gastrojejunostomy (EUS-GJ)	Surgical gastrojejunostomy (S-GJ)	Patients on this arm will undergo the endoscopic procedure.

Primary Outcome Measures

Name	Time	Method
Identify safety profile EUS-GJ	24 Months	The severity of AEs will be determined using standard American Society of Gastrointestinal Endoscopy (ASGE) Lexicon and AGREE criteria (appendix) in the EUS-GJ group.

Secondary Outcome Measures

Name	Time	Method
Identify safety profile for S-GJ	24 Months	The severity of AEs will be determined using Claviden-Dindo classification of surgical complications in the S-GJ group.

Trial Locations

Locations (1)

AdventHealth Orlando; 🇺🇸 Orlando, Florida, United States