Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices

Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices Based on CT Hemodynamics

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal and Gastric Varices
• Intervention / Treatment: Procedure: Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices; Procedure: Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices; Procedure: Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)

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 Type: Interventional
• Enrollment (Estimated): 57
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongxia Li, Doctor; Phone Number: +8618252006898; Email: lhx100918@163.com
• Study Contact Backup: Name: Wei Wei, Master; Phone Number: +8615267175186; Email: wwze@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A; 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; For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with ligation.
Active Comparator: B; 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; For patients with GOV1 esophagogastric varices, gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will be treated with sclerotherapy.
Experimental: C; 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); For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemostasis rate	the percentage of hemostasis	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative bleeding recurrence rate	Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease >10g/L	6 month

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Collaborators: Shandong Provincial Hospital Affiliated to Shandong First Medical University; Lishui Country People's Hospital; Lanxi People's Hospital; Jinhua Hospital Affiliated to Zhejiang University
• Investigators: Study Director: Wei Li, Master, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China; Study Chair: Liangjing Wang, Doctor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: HVPG; endoscopic treatment; GOV1 esophagogastric varices
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins
• Other Study ID Numbers: 2023-0437

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No