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

April 23, 2026 updated by: AdventHealth

A Randomized Trial Comparing Endoscopic UltraSound-guided GasTrojejunostomy (EUS-GJ) and Surgical GastrojejunOstomy (S-GJ) for the Management of Malignant gastRic outlEt Obstruction

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • AdventHealth Orlando
        • Contact:
        • Principal Investigator:
          • Kambiz Kadkhodayan, MD
        • Sub-Investigator:
          • Dennis Yang, MD
        • Sub-Investigator:
          • Natalie Cosgrove, MD
        • Sub-Investigator:
          • Deepanshu Jain, MD
        • Sub-Investigator:
          • Sebastian De La Fuente, MD
        • Sub-Investigator:
          • Armando Rosales, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: EUS-guided gastrojejunostomy (EUS-GJ)
Patients on this arm will undergo the endoscopic procedure.
Procedure: Surgical gastrojejunostomy (S-GJ)
Surgical gastro-jejunostomy
Other: Surgical gastrojejunostomy (S-GJ)
Patients on this arm will undergo the surgical procedure.
Procedure: EUS-guided gastrojejunostomy (EUS-GJ)
Endoscopic Ultrasound guided gastro-jejunostomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify safety profile EUS-GJ
Time Frame: 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.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify safety profile for S-GJ
Time Frame: 24 Months
The severity of AEs will be determined using Claviden-Dindo classification of surgical complications in the S-GJ group.
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Kambiz Kadkhodayan, MD, AdventHealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

September 8, 2026

Study Completion (Estimated)

March 8, 2027

Study Registration Dates

First Submitted

October 24, 2023

First Submitted That Met QC Criteria

November 9, 2023

First Posted (Actual)

November 13, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2036763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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