Clip and Coil in Fundal Gastric Varices With a Large Shunt

November 24, 2025 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

Clip and Coil: A Novel Safe Strategy in Managing Fundal Gastric Varices With a Large Spontaneous Portosystemic Shunt

Endoscopic ultrasound (EUS)-guided coil deployment is a promising technique for the endoscopic management of gastric varices. However, coil migration may occur in patients with large drainage collaterals. This study aimed to evaluate the safety and efficacy of using clips in combination with coils for treating gastric varices. In this retrospective study, clips were placed before EUS-guided coil deployment in each patient with gastric varices and a large spontaneous portosystemic shunt. The pressure of gastric varices was directly measured by puncturing the varix with a needle connected to a pressure transducer, before and after clip placement. The occurrence of ectopic embolization or coil migration was recorded.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hangzhou, China
        • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with fundal gastric varices, admitted for endoscopic intervention

Description

Inclusion Criteria:

  1. presence of a spontaneous portosystemic shunt, including gastrorenal or splenorenal collateral shunts;
  2. use of both clips and coils during endoscopic intervention.

Exclusion Criteria:

The spontaneous portosystemic shunt was narrow (diameter < 1.0 cm).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Fundal gastric varices associated with a large spontaneous portosystemic shunt (>1cm)
Clips were placed before EUS-guided coil deployment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The occurrence of ectopic embolization
Time Frame: Within the day of the endoscopic intervention (after the operation)
Within the day of the endoscopic intervention (after the operation)

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of coil migration
Time Frame: Within the day of the endoscopic intervention (after the operation)
Within the day of the endoscopic intervention (after the operation)

Other Outcome Measures

Outcome Measure
Time Frame
Gastric variceal pressure gradient
Time Frame: During the endoscopic intervention
During the endoscopic intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Actual)

October 16, 2025

Study Completion (Actual)

October 31, 2025

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 2025-1588

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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