RECRUITING

Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

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

Gastric outlet obstruction (GOO) occurs commonly in malignancies involving the periampullary region (cancers originating in the head of the pancreas, duodenum, bile duct, or ampulla) or the distal stomach. GOO not only causes debilitating symptoms such as nausea, vomiting, inability to tolerate oral intake, and prevents adequate nutritional intake. Therefore, providing therapy for GOO is imperative to improve the quality of life, and nutritional status of these patients, as well as allow them to continue receiving their cancer treatment

Official Title

Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy

Quick Facts

Study Start:2022-10-28
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05561907

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. Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
  2. 2. Symptoms of gastric outlet obstruction (at least 2 of 4 required):
  3. 1. post prandial vomiting,
  4. 2. abdominal pain,
  5. 3. inability to tolerate PO,
  6. 4. imaging consistent with GOO
  7. 3. Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)
  8. 4. Age \>18 years old
  9. 5. Life expectancy greater than 2 months or failed duodenal stenting
  10. 6. Surgical Candidate/Tolerate General Anesthesia
  11. 7. Unresectable or metastatic disease
  1. 1. Age\< 18 years old
  2. 2. Pregnancy
  3. 3. Intestinal obstruction distal to the Ligament of Treitz
  4. 4. Evidence of other luminal strictures of the GI tract
  5. 5. Previous gastric or periampullary surgery
  6. 6. Inability to complete quality of life surveys (QOLS)
  7. 7. Presence of abdominal ascites

Contacts and Locations

Study Contact

Molly Stewart
CONTACT
718-470-4667
mstewart8@northwell.edu
Hye Jeong Jang
CONTACT
718-470-7983
hjang3@northwell.edu

Principal Investigator

Petros Benias, MD
PRINCIPAL_INVESTIGATOR
Northwell Health
Arvind Trindade, MD
PRINCIPAL_INVESTIGATOR
Northwell Health

Study Locations (Sites)

North Shore University Hospital
Manhasset, New York, 11030
United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
United States
Lenox Hill Hospital
New York, New York, 10075
United States

Collaborators and Investigators

Sponsor: Northwell Health

  • Petros Benias, MD, PRINCIPAL_INVESTIGATOR, Northwell Health
  • Arvind Trindade, MD, PRINCIPAL_INVESTIGATOR, Northwell 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 Date2022-10-28
Study Completion Date2025-06

Study Record Updates

Study Start Date2022-10-28
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Gastric outlet obstruction
  • GOO
  • Periampullary malignancy
  • Periampullary cancer
  • Surgical gastrojejunostomy
  • Endoscopic gastrojejunostomy
  • Gastrojejunostomy
  • Enteral anastamosis

Additional Relevant MeSH Terms

  • Gastric Outlet Obstruction