search
Back to results

Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices

Primary Purpose

Esophageal and Gastric Varices

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices
Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices
Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal and Gastric Varices focused on measuring GOV1 esophagogastric varices, HVPG, endoscopic treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    A

    B

    C

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    hemostasis rate
    the percentage of hemostasis

    Secondary Outcome Measures

    Postoperative bleeding recurrence rate
    Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease >10g/L

    Full Information

    First Posted
    July 31, 2023
    Last Updated
    August 22, 2023
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Jinhua Hospital Affiliated to Zhejiang University, Lanxi People's Hospital, Lishui Country People's Hospital, Shandong Provincial Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05978752
    Brief Title
    Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices
    Official Title
    Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices Based on CT Hemodynamics
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    November 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    Jinhua Hospital Affiliated to Zhejiang University, Lanxi People's Hospital, Lishui Country People's Hospital, Shandong Provincial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Esophageal and Gastric Varices
    Keywords
    GOV1 esophagogastric varices, HVPG, endoscopic treatment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    57 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Active Comparator
    Arm Description
    The patients will undergo endoscopic gel embolization of gastric fundus varices and esophageal varices ligation.
    Arm Title
    B
    Arm Type
    Active Comparator
    Arm Description
    The patients will undergo endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices.
    Arm Title
    C
    Arm Type
    Experimental
    Arm Description
    The patients will undergo endoscopic gelatinization of gastric varices (esophageal varices were not treated).
    Intervention Type
    Procedure
    Intervention Name(s)
    Endoscopic gel embolization of gastric fundus varices and ligation of esophageal varices
    Intervention Description
    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
    Intervention Name(s)
    Endoscopic gel embolization of gastric fundus varices and sclerotherapy of esophageal varices
    Intervention Description
    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
    Intervention Name(s)
    Endoscopic gelatinous embolization of gastric varices (esophageal varices not treated)
    Intervention Description
    For patients with GOV1 esophagogastric varices, only gastric varices will be treated with endoscopic gelatinous embolization, esophageal varices will not be treated.
    Primary Outcome Measure Information:
    Title
    hemostasis rate
    Description
    the percentage of hemostasis
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Postoperative bleeding recurrence rate
    Description
    Rebleeding rate after endoscopic treatment: including hematemesis and/or black stool, hemoglobin decrease >10g/L
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hongxia Li, Doctor
    Phone
    +8618252006898
    Email
    lhx100918@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Wei, Master
    Phone
    +8615267175186
    Email
    wwze@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wei Li, Master
    Organizational Affiliation
    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Liangjing Wang, Doctor
    Organizational Affiliation
    2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study on Endoscopic Management of GOV1 Esophagogastric Varices

    We'll reach out to this number within 24 hrs