ACTIVE_NOT_RECRUITING

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

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

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

Official Title

Randomized Trial Comparing Endoscopic Ultrasound-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

Quick Facts

Study Start:2022-09-16
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05548114

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. Age ≥ 18 years
  2. 2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
  3. 3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
  4. 4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy
  1. 1. Age \< 18 years
  2. 2. Intrauterine pregnancy
  3. 3. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
  4. 4. Unable to obtain consent for the procedure from either the patient or LAR
  5. 5. Altered anatomy due to prior gastroduodenal surgery
  6. 6. Presence of other adhesions or synchronous obstructive lesions in the small bowel
  7. 7. Prior treatment for gastric outlet obstruction
  8. 8. Presence of large volume malignant ascites

Contacts and Locations

Principal Investigator

Ji Young Bang, MD MPH
PRINCIPAL_INVESTIGATOR
Orlando Health

Study Locations (Sites)

Orlando Health
Orlando, Florida, 32806
United States

Collaborators and Investigators

Sponsor: Orlando Health, Inc.

  • Ji Young Bang, MD MPH, PRINCIPAL_INVESTIGATOR, Orlando Health

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 Date2022-09-16
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-09-16
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • Gastric outlet obstruction
  • Endoscopic ultrasound
  • Surgery
  • Malignancy
  • Gastrojejunostomy

Additional Relevant MeSH Terms

  • Gastric Outlet Obstruction