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

RECRUITINGN/ASponsored by Northwell Health
Actively Recruiting
PhaseN/A
SponsorNorthwell Health
Started2022-10-28
Est. completion2024-05
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations3 sites

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerGastric Outlet Obstruction

Locations3 sites

North Shore University Hospital
Manhasset, New York, 11030
Molly Stewart718-470-4667mstewart8@northwell.edu
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Molly Stewart718-470-4667mstewart8@northwell.edu
Lenox Hill Hospital
New York, New York, 10075
Molly Stewart718-470-4667mstewart8@northwell.edu

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