Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
Recruiting now · Not applicable
Conditions studied: Gastric Outlet Obstruction
In brief
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
Key facts
- Study ID
- NCT05561907
- Run by
- Northwell Health
- People needed
- 32
- Starts
- 2022-10-28
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Periampullary malignancy (pancreas, bile duct, ampulla, duodenum) extending to the distal duodenum (D3) or distal (antrum) gastric cancer
- Symptoms of gastric outlet obstruction (at least 2 of 4 required):
- post prandial vomiting,
- abdominal pain,
- inability to tolerate PO,
- imaging consistent with GOO
- Gastric Outlet Obstruction Scoring System (GOOSS) Score of 0 (no oral intake) or 1 (liquids only)
- Age >18 years old
- Life expectancy greater than 2 months or failed duodenal stenting
- Surgical Candidate/Tolerate General Anesthesia
- Unresectable or metastatic disease
You may not qualify if…
- Age< 18 years old
- Pregnancy
- Intestinal obstruction distal to the Ligament of Treitz
- Evidence of other luminal strictures of the GI tract
- Previous gastric or periampullary surgery
- Inability to complete quality of life surveys (QOLS)
- Presence of abdominal ascites
Where it is running
- Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
- North Shore University Hospital — Manhasset, New York, United States
- Long Island Jewish Medical Center — New Hyde Park, New York, United States
- Lenox Hill Hospital — New York, New York, United States
Full record on ClinicalTrials.gov
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