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

RecruitingNAAges 18 Years - anyAllNorthwell Health
NCT05561907 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion 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 Exclusion Criteria: 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
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What it tests

  • Surgical gastrojejunostomy (SGJ)
  • Endoscopic gastrojejunostomy (EGJ)
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Where

4 sites
Robert Wood Johnson University Hospital
New Brunswick, United States
North Shore University Hospital
Manhasset, United States
Long Island Jewish Medical Center
New Hyde Park, United States
Lenox Hill Hospital
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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