Clip and Coil in Fundal Gastric Varices With a Large Shunt | NCT07263503

Studies
Clip and Coil in Fundal Gastric Varices With a Large Shunt

NCT07263503

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Completed

Last Update Posted

Dec 4, 2025Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Fundal Gastric Varices
Endoscopic Ultrasound (EUS)-Guided Coil Deployment
Titanium Clips
Ectopic Embolization
Gastric Variceal Pressure

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2024Actual

Primary Completion Date

Oct 16, 2025Actual

Completion Date

Oct 31, 2025Actual

First Submitted Date

Nov 24, 2025

First Submission Date that Met QC Criteria

Nov 24, 2025

First Posted Date

Dec 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2025

Last Update Posted Date

Dec 4, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fundal gastric varices associated with a large spontaneous portosystemic shunt (>1cm)		Clips were placed before EUS-guided coil deployment

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Gastric variceal pressure gradient		During the endoscopic intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with fundal gastric varices, admitted for endoscopic intervention

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated Hospital of Zhejiang University School of Medicine		Hangzhou			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided