Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices

Not Applicable

Not yet recruiting

• Conditions: Esophageal and Gastric Varices

• Registration Number: NCT05978752
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-07
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24
• Study Start: 2023-12
• Primary Completion: 2025-06
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 57

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
hemostasis rate	6 month	the percentage of hemostasis

Secondary Outcome Measures

Name	Time	Method
Postoperative bleeding recurrence rate	6 month	Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease \>10g/L