NCT05978752

Brief Summary

The patients with GOV1 esophagogastric varices will be treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices will be proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding HVPG testing to develop the best strategy for secondary prevention of endoscopic treatment in patients with GOV1 type esophageal and gastric varices.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

August 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

July 31, 2023

Last Update Submit

August 22, 2023

Conditions

Esophageal and Gastric Varices

Keywords

GOV1 esophagogastric varicesHVPGendoscopic treatment

Outcome Measures

Primary Outcomes (1)

  • hemostasis rate

    the percentage of hemostasis

    6 month

Secondary Outcomes (1)

  • Postoperative bleeding recurrence rate

    6 month

Study Arms (3)

A

ACTIVE COMPARATOR

The patients will undergo endoscopic gel embolization of gastric fundus varices and esophageal varices ligation.

Procedure: Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices

B

ACTIVE COMPARATOR

The patients will undergo endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices.

Procedure: Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices

C

EXPERIMENTAL

The patients will undergo endoscopic gelatinization of gastric varices (esophageal varices were not treated).

Procedure: Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)

Interventions

Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varicesPROCEDURE

For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with ligation.

A
Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varicesPROCEDURE

For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with sclerotherapy.

B
Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)PROCEDURE

For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated.

C

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • GOV1 esophageal and gastric varices identified by CT; more than 18 years old;

You may not qualify if:

  • Complicated with liver cancer, severe cardiopulmonary insufficiency, stage III and above hepatic encephalopathy, severe natural portal shunt formation, and previous treatment of portal hypertensive bleeding (including endoscopic, interventional, and surgical procedures).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Wei Li, Master

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    STUDY DIRECTOR

  • Liangjing Wang, Doctor

    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

    STUDY CHAIR

Central Study Contacts

Hongxia Li, Doctor

CONTACT

+8618252006898lhx100918@163.com

Wei Wei, Master

CONTACT

+8615267175186wwze@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The patients with GOV1 esophagogastric varices were treated with gastric variceal tissue gel injection, at the same time, the esophageal varices were treated with ligation, sclerotherapy, or no treatment. A new method for the treatment of esophageal varices was proposed to improve the effective rate and reduce the recurrence rates and mortality, shorter hospital stays, and lower treatment costs, while further expanding the value of HVPG testing.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

December 1, 2023

Primary Completion

June 1, 2025

Study Completion

November 1, 2025

Last Updated

August 24, 2023

Record last verified: 2023-07