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

Last updated: June 9, 2025
Sponsor: Orlando Health, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Vomiting

Treatment

Surgical gastrojejunostomy

EUS-guided gastrojejunostomy

Clinical Study ID

NCT05548114
22.127.06
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥ 18 years

  2. Presence of gastric outlet or duodenal obstruction on any imaging or endoscopy fromknown or suspected inoperable malignancy

  3. Gastric outlet obstruction Scoring System (GOOSS) of ≤ 1 (defined as maximum oralintake of liquids only)

  4. Amenable to treatment by both EUS-guided and surgical gastrojejunostomy

Exclusion

Exclusion Criteria:

  1. Age < 18 years

  2. Intrauterine pregnancy

  3. Use of anticoagulants that cannot be discontinued for the procedure or irreversiblecoagulopathy

  4. Unable to obtain consent for the procedure from either the patient or LAR

  5. Altered anatomy due to prior gastroduodenal surgery

  6. Presence of other adhesions or synchronous obstructive lesions in the small bowel

  7. Prior treatment for gastric outlet obstruction

  8. Presence of large volume malignant ascites

Study Design

Total Participants: 74
Treatment Group(s): 2
Primary Treatment: Surgical gastrojejunostomy
Phase:
Study Start date:
September 16, 2022
Estimated Completion Date:
December 31, 2025

Study Description

Malignant gastric outlet obstruction (GOO) results from the mechanical obstruction of the duodenum or distal stomach from an underlying cancer. The consequences of GOO are abdominal pain, nausea, vomiting, anorexia, inability to maintain an oral diet and weight loss, with associated poor quality of life and inability to continue with cancer therapy. 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.

Connect with a study center

  • Orlando Health

    Orlando, Florida 32806
    United States

    Site Not Available

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