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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06128018

Acronym

RESTORE

Enrollment

Registered

2023-11-13

Start date

2023-11-01

Completion date

2027-03-08

Last updated

2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Gastric Outlet Obstruction

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

Interventions

PROCEDURESurgical gastrojejunostomy (S-GJ)

Surgical gastro-jejunostomy

PROCEDUREEUS-guided gastrojejunostomy (EUS-GJ)

Endoscopic Ultrasound guided gastro-jejunostomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

CONTACTBridget Miller, MPH, MS

bridget.miller@adventhealth.com(407)303-9736

CONTACTPetronio Martins

Petronio.martins@adventhealth.com(407)303-5503

PRINCIPAL_INVESTIGATORKambiz Kadkhodayan, MD

AdventHealth

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026