Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Stud… (NCT05561907) | Clinical Trial Compass
UnknownNot Applicable
Enteral Anastomosis for the Treatment of Gastric Outlet Obstruction: A Randomized Controlled Study Comparing Endoscopic Versus Surgical Gastrojejunostomy
United States32 participantsStarted 2022-10-28
Plain-language 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
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Age\< 18 years old
✕. Pregnancy
✕. Intestinal obstruction distal to the Ligament of Treitz
What they're measuring
1
Time to initiation of solid oral intake without symptoms of GOO