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

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

Conditions

Gastric Outlet Obstruction

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Gastric Outlet Obstruction
Intervention / Treatment

-

Contacts and Locations

Manhasset

North Shore University Hospital, Manhasset, New York, United States, 11030

New Hyde Park

Long Island Jewish Medical Center, New Hyde Park, New York, United States, 11040

New York

Lenox Hill Hospital, New York, New York, United States, 10075

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwell Health,

Petros Benias, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Arvind Trindade, MD, PRINCIPAL_INVESTIGATOR, Northwell Health

Study Record Dates

2025-06