Status:

NOT_YET_RECRUITING

Novel Balloon-Assisted vs Direct Technique in EUS-Guided Gastroenterostomy

Lead Sponsor:

Changhai Hospital

Conditions:

Gastric Outlet Obstruction

Eligibility:

All Genders

18-80 years

Phase:

NA

Brief Summary

Gastric outlet obstruction (GOO) refers to mechanical blockage at the pylorus or duodenum, most commonly caused by unresectable malignancies of the stomach, duodenum, or pancreas. At the time of diagn...

Detailed Description

This multicenter, single-blind, RCT is designed to enroll 272 patients across five high-volume tertiary referral centers in China. The study is planned to commence in July 2025 and continue until the ...

Eligibility Criteria

Inclusion

  • Age ranges from 18 to 80 years old
  • GOO patients caused by all reasons (including benign diseases such as ulcers or malignant tumors)
  • Not suitable for or cannot tolerate surgical operations and endoscopic intestinal stent implantation
  • There are no absolute contraindications for EUS-GE
  • Signed informed consents

Exclusion

  • Pregnant and lactating women
  • Unable or refused to provide informed consents
  • Patients with cognitive impairment, aphasia, mental disorders, or other conditions that may affect the patient's cooperation
  • Patients with endoscopic contraindications, anesthesia contraindications, digestive tract perforation or abdominal cavity infection
  • The tumor invades the duodenum or the upper segment of the jejunum Individuals whom the investigator deems unsuitable for participation

Key Trial Info

Start Date :

September 1 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

August 1 2026

Estimated Enrollment :

272 Patients enrolled

Trial Details

Trial ID

NCT07161856

Start Date

September 1 2025

End Date

August 1 2026

Last Update

September 9 2025

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