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NCT Number: NCT06128018

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location status: Recruiting

Location contact

Armando Rosales, MD

SUB_INVESTIGATOR

Deepanshu Jain, MD

SUB_INVESTIGATOR

Dennis Yang, MD

SUB_INVESTIGATOR

Diana Paredes, RN

CONTACT

[email protected]

(407) 303-9736

Kambiz Kadkhodayan, MD

PRINCIPAL_INVESTIGATOR

Natalie Cosgrove, MD

SUB_INVESTIGATOR

Petronio Martins, MHA

CONTACT

[email protected]

(407) 303-5503

Sebastian De La Fuente, MD

SUB_INVESTIGATOR

About this study

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:

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Surgical gastrojejunostomy (S-GJ)

Procedure

Surgical gastro-jejunostomy

EUS-guided gastrojejunostomy (EUS-GJ)

Procedure

Endoscopic Ultrasound guided gastro-jejunostomy

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Paredes

CONTACT

[email protected]

(407)303-9736

Petronio Martins

CONTACT

[email protected]

(407)303-5503

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Registry information

Official study title

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

Acronym: RESTORE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Nov 13, 2023
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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