Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices

Esophageal and Gastric Varices Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05978752
• Other study ID #: 2023-0437
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2023
• Est. completion date: November 2025

Study information

• Verified date: July 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Hongxia Li, Doctor
• Phone: +8618252006898
• Email: lhx100918[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 57
• Est. completion date: November 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Varicose Veins

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	Jinhua Hospital Affiliated to Zhejiang University, Lanxi People's Hospital, Lishui Country People's Hospital, Shandong Provincial Hospital Affiliated to Shandong First Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemostasis rate	the percentage of hemostasis	6 month
Secondary	Postoperative bleeding recurrence rate	Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease >10g/L	6 month