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OTSC vs. Angiographic Embolization in Patients With Refractory Non-variceal Upper Gastrointestinal Bleeding

NCT04902248 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-03-18

No results posted yet for this study

Summary

In the management of patients with acute upper non-variceal upper gastrointestinal bleeding, further bleeding is the most important adverse factor predictive of mortality. In the United Kingdom Audit on acute upper gastrointestinal bleeding, clinical evidence of further bleeding was reported in 13% of patients following the first endoscopy and 27% of them died. The use of OTSC has emerged as an alternative before angiographic embolization(TAE) which is often considered most definitive.

We propose to define the algorithm in the management of patients with refractory bleeding from their peptic ulcers or other non variceal causes. We hypothesize that endoscopic use of OTSC compares favourably with TAE and both lead to similar outcomes. An equivalence of the two modalities may mean that endoscopic application of OTSC should be attempted before TAE as often we need to document further bleeds with endoscopy and a second treatment should be instituted at the same time.

Conditions

  • Upper Gastrointestinal Bleeding

Interventions

DEVICE

The OTSC® System Set

The endoscope was extracted and equipped with the OTSC system. OTSC system is deployed on the lesion with suction to target lesion

PROCEDURE

angiographic embolization

Transcatheter selective embolization to bleeding arteries

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Yau Wong James Lau, MD · The Chinese University of HongKong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-27
Primary Completion
2026-05-31
Completion
2026-11-30

Countries

  • China
  • Hong Kong
  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04902248 on ClinicalTrials.gov