Detachable Clip-assisted Endoscopic Cyanoacrylate Injection in the Treatment of Gastric Varices

NCT ID: NCT06670157

Last Updated: 2024-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-10-30

Brief Summary

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A single-arm exploratory clinical study design was used to evaluate the safety and efficacy of a "modified sandwich injection" of tissue glue assisted by a detachable clip for the treatment of gastric varicose veins.

Detailed Description

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Conditions

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Gastric Varices Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Detachable Clip-assisted

After the varicose vessel is closed with a removable titanium clamp, the more varicose target vessel is located,After the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed

Group Type EXPERIMENTAL

Detachable Clip

Intervention Type OTHER

After the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed

Interventions

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Detachable Clip

After the varicose vessels basically disappeared under the endoscope, the removable titanium clamp was removed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* The subject voluntarily signs the informed consent for this experiment; According to clinical manifestation, laboratory examination, imaging examination, or liver biopsy in the diagnosis of liver cirrhosis patients; The endoscopy diagnosed gastric varices (gastroesophageal varices, gastroesophageal varices type 2 or type 1 isolated gastric varices type 1); High risk of gastric varices or has a history of gastric varices bleeding. The initial fluid resuscitation patients before or after the recovery hemodynamic stability; The age of 18 years old or more.

Exclusion Criteria

* \< 18 years old; Regional portal hypertension; Always have a liver transplant, via the jugular intrahepatic portal vein system bypass or splenectomy combined varices cut-out art history; A concurrent hepatorenal syndrome and/or multiple organ failure; Significant impact on survival of malignant tumor; Pregnancy or lactation; A known allergy to iodine.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yu Chang

OTHER

Sponsor Role lead

Responsible Party

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Yu Chang

student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ji xuan, doctor

Role: PRINCIPAL_INVESTIGATOR

Eastern Theater General Hospital

Locations

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Eastern Theater General Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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ji xuan, doctor

Role: CONTACT

13140718720

yu chang, master

Role: CONTACT

18175226948

Facility Contacts

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yu chang, Master

Role: primary

18175226948

Other Identifiers

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DZQH-KYLL-24-16

Identifier Type: -

Identifier Source: org_study_id

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