Active — Not RecruitingNot Applicable

Randomized Trial of EUS-guided Gastrojejunostomy and Surgical Gastrojejunostomy in Gastric Outlet Obstruction

United States74 participantsStarted 2022-09-16

Plain-language summary

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The aim of this study is to compare the clinical outcomes between surgical gastrojejunostomy and EUS-guided gastrojejunostomy in patients with malignant gastric outlet obstruction.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Age ≥ 18 years
✓. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy from known or suspected inoperable malignancy
✓. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oral intake of liquids only)
✓. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy

Exclusion criteria

✕. Age \< 18 years
✕. Intrauterine pregnancy
✕. Use of anticoagulants that cannot be discontinued for the procedure or irreversible coagulopathy
✕. Unable to obtain consent for the procedure from either the patient or LAR
✕. Altered anatomy due to prior gastroduodenal surgery
✕. Presence of other adhesions or synchronous obstructive lesions in the small bowel
✕. Prior treatment for gastric outlet obstruction
✕. Presence of large volume malignant ascites

What they're measuring

Composite end point of inability to tolerate a solid diet (defined as gastric outlet obstruction scoring system score <2) or requiring additional interventions or supplemental nutrition or procedure-related adverse events.

Timeframe: 6 months

Trial details

NCT IDNCT05548114

SponsorOrlando Health, Inc.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06

View on ClinicalTrials.gov More Gastric Outlet Obstruction trials