Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO. (RESTORE)

AdventHealth

Status: Enrolling

Conditions: Malignant Gastric Outlet Obstruction

Treatments: Procedure: EUS-guided gastrojejunostomy (EUS-GJ); Procedure: Surgical gastrojejunostomy (S-GJ)

Study type: Interventional

Funder types: Other

Identifiers

NCT06128018

2036763

Details and patient eligibility

About

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

Full 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

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

EUS-guided gastrojejunostomy (EUS-GJ)

Other group

Description:

Patients on this arm will undergo the endoscopic procedure.

Treatment:

Procedure: Surgical gastrojejunostomy (S-GJ)

Surgical gastrojejunostomy (S-GJ)

Other group

Description:

Patients on this arm will undergo the surgical procedure.

Treatment:

Procedure: EUS-guided gastrojejunostomy (EUS-GJ)