Status:

ENROLLING_BY_INVITATION

Endoscopic Gastroenterostomy Versus Surgical Gastrojejunostomy

Lead Sponsor:

Vanderbilt University Medical Center

Conditions:

Malignant Gastric Outlet Obstruction

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Recent comparative data suggest that EUS gastroenterostomy offers more durable patency than enteral stents for treatment of malignant GOO, leading some endoscopists to suggest that EUS gastroenterosto...

Eligibility Criteria

Inclusion

  • Age 18 years or older
  • Able to provide informed consent
  • Biopsy-proven cancer
  • Cancer without surgical resection as a curative treatment option
  • Clinical and radiographic presentation consistent with primary or metastatic tumor causing foregut obstruction at the level of the pylorus and/or duodenum

Exclusion

  • Age \<18 years
  • Pregnancy
  • Unable to provide informed consent
  • White Blood Count \< 3,000
  • Absolute Neutrophil Count \< 1,500
  • International normalized ratio \> 1.6
  • Platelet count \< 100,000
  • Cancer with surgical resection as a curative treatment option
  • Surgically altered foregut anatomy
  • Multifocal intestinal obstruction
  • Abdominal ascites prohibitive of surgical candidacy
  • Abdominal wall mesh prohibitive of surgical candidacy
  • Child's Class B or C cirrhosis
  • Gastroesophageal varices or known portal hypertension
  • Body mass index \>40

Key Trial Info

Start Date :

August 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2027

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT06567691

Start Date

August 1 2025

End Date

January 1 2027

Last Update

August 26 2025

Active Locations (1)

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1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37212