RECRUITING

Comparing Endoscopic Ultrasound vs Surgical Gastrojejunostomy for Management of GOO.

Talk to us

Conditions

Malignant Gastric Outlet Obstruction

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-11-01
Study Completion:2026-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06128018

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. ≥ 18 years of age.
  2. 2. Radiographic OR Endoscopic evidence of an obstructing neoplasm in the distal stomach or duodenum.
  3. 3. GOOSS of 0 or 1
  4. 4. BOTH surgical and endoscopic GJ are technically and clinically feasible
  5. 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).
  1. 1. \< 18 years of age
  2. 2. ECOG \>2
  3. 3. Expected survival (determined by the treating oncologist) is less than 2 months.
  4. 4. Candidates for potential resection of the cancer and obstructed anatomical area (this includes patients with borderline resectable pancreatic cancer)
  5. 5. Peritoneal carcinomatosis with associated bowel obstruction on imaging or during laparoscopy
  6. 6. Large volume ascites (patients with moderate volume ascites may undergo IR guided drainage prior to randomization)
  7. 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. 8. Pregnancy

Contacts and Locations

Study Contact

Diana Paredes
CONTACT
(407)303-9736
Diana.Paredes@adventhealth.com
Petronio Martins
CONTACT
(407)303-5503
Petronio.martins@adventhealth.com

Principal Investigator

Kambiz Kadkhodayan, MD
PRINCIPAL_INVESTIGATOR
AdventHealth

Study Locations (Sites)

AdventHealth Orlando
Orlando, Florida, 32804
United States

Collaborators and Investigators

Sponsor: AdventHealth

  • Kambiz Kadkhodayan, MD, PRINCIPAL_INVESTIGATOR, AdventHealth

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 Registration Dates

Study Start Date2023-11-01
Study Completion Date2026-07-31

Study Record Updates

Study Start Date2023-11-01
Study Completion Date2026-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Malignant Gastric Outlet Obstruction