Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices

NCT ID: NCT05978752

Last Updated: 2023-08-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2025-11-30

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.

Detailed Description

Cirrhotic portal hypertension can cause esophageal and gastric varices, and esophageal and gastric varices bleeding (EGVB) were associated with portal vein pressure. At present, the gold standard for detecting portal pressure in clinical practice is hepatic venous pressure gradient (HVPG). For Sarin classification GOV1 of esophagogastric varices are from a single origin, the left gastric vein. If the fundus varicose veins receive complete embolization treatment, the esophageal variceal blood flow should be completely blocked, and such patients do not need to perform esophageal surgery. However, this has not been reported in the literature.

Patients with esophageal and gastric varices identified by CT as GOV1 will be enrolled, all of whom will receive HVPG detects. The patients were randomly divided into three groups. The patients in group A will receive endoscopic gel embolization for gastric varices and esophageal varices ligation treatment, group B patients will receive endoscopic gastric variceal tissue glue embolization and esophageal variceal sclerotherapy treatment, the patients in group C will receive endoscopic gelatinization of gastric fundus varices (esophageal varices were not treated). Patients in the three groups were followed up with CTP and gastroscopy 1 month, 3 months, and 6 months after the initial treatment, and additional endoscopic treatment will be provided if necessary. If bleeding occurs again during this period, timely treatment (medication, endoscopy, intervention or surgery) is required according to the condition.

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.

Conditions

Esophageal and Gastric Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

B

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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

C

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

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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

Interventions

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

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

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

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

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinhua Hospital Affiliated to Zhejiang University

UNKNOWN

Sponsor Role: collaborator

Lanxi People's Hospital

OTHER

Sponsor Role: collaborator

Lishui Country People's Hospital

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Li, Master

Role: STUDY_DIRECTOR

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

Liangjing Wang, Doctor

Role: STUDY_CHAIR

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

Central Contacts

Hongxia Li, Doctor

Role: CONTACT

lhx100918@163.com

+8618252006898

Wei Wei, Master

Role: CONTACT

wwze@zju.edu.cn

+8615267175186

Other Identifiers

2023-0437

Identifier Type: -

Identifier Source: org_study_id