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Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices

Primary Purpose

Gastroesophageal Varices, Liver Cirrhosis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gastric variceal ligation
gastric variceal obturation
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastroesophageal Varices

Eligibility Criteria

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

Inclusion Criteria:

  • Patients over 18 years of age;Past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination

Exclusion Criteria:

  • Patients who are not suitable for endoscopic treatment judged by the clinician; Patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; Patients with acute hemorrhage

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    gastric variceal obturation

    gastric variceal ligation

    Arm Description

    gastric variceal obturation

    gastric variceal ligation

    Outcomes

    Primary Outcome Measures

    Rate of rebleeding
    New onset of hematemesis, coffee-ground vomitus, hematochezia,or melena,with an increasing pulse rate over 100 beats/min and decreasing blood pressure below 90 mmHg after a 24-hour period of stable vital signs and hemoglobin after endoscopic treatment.

    Secondary Outcome Measures

    Rate of GV eradication
    non-visualization of patent GV
    Incidence of complications
    Huge ulcer on GV, spontaneous bacterial peritonitis, bacteremia
    mortality
    Survival situation of patience

    Full Information

    First Posted
    October 31, 2018
    Last Updated
    November 1, 2018
    Sponsor
    Shanghai Zhongshan Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03729921
    Brief Title
    Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices
    Official Title
    Comparison of Efficacy and Safety of Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2018 (Anticipated)
    Primary Completion Date
    November 2019 (Anticipated)
    Study Completion Date
    June 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Zhongshan 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 investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs. Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.
    Detailed Description
    Gastric varices (GVs) is a common complication of portal hypertension, with an incidence of 20%. Though the bleeding rate of GVs (25%) is lower than that of Esophageal varices (EVs), the mortality rate is higher due to greater GVs rupture and less space for endoscopic intervention. In addition, in 30% of patients with GVs, the possibility of treatment failure exists. Guidelines differ on endoscopic treatment for secondary prevention of GVs.Current studies suggest that EVL, due to its low incidence of complications, is suitable for GOV1, while it is still controversial for the treatment of gastric varices. Compared with glue, the advantage of ligation is that it can avoid serious complications caused by glue injection, such as ectopic embolization, large ulcer and sepsis. As there are few studies comparing GVL and GVO in secondary prevention of gastric varices, the treatment methods are different, and the treatment effect is controversial. In addition, the choice of treatment for different types of GVs needs further study. The investigators establish a randomized controlled clinical trial, comparing the efficacy and prognosis of GVL and GVO in secondary prevention of GVs, especially in patients with portosystemic shunting, and exploring the endoscopic treatment selection of different types of GVs. Outcome expectations: Compared with glue injection, endoscopic ligation for secondary prevention of gastric varices is safe and effective, especially in patients with portosystemic shunting.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gastroesophageal Varices, Liver Cirrhosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    166 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    gastric variceal obturation
    Arm Type
    Active Comparator
    Arm Description
    gastric variceal obturation
    Arm Title
    gastric variceal ligation
    Arm Type
    Experimental
    Arm Description
    gastric variceal ligation
    Intervention Type
    Procedure
    Intervention Name(s)
    gastric variceal ligation
    Intervention Description
    The highest point of the variceal vein was used as the primary ligation site. If the input vein was not obvious, the edge of the variceal vein was ligated. The variceal veins were ligated with a 6-ring ligation device, and more than 18 rings rubber bands could be applied in one session. GVL was performed regularly until varices were obliterated or reduced to residual small varices, which could not be ligated. The residual small varices was treated by cyanoacrylate injection.
    Intervention Type
    Procedure
    Intervention Name(s)
    gastric variceal obturation
    Intervention Description
    Gastric varices were uniformly treated via the sandwich technique, which starts with an injection of lauromacrogol, followed by N-butyl cyanoacrylate, then finished with flush of lauromacrogol. The number of injection sites and volume of lauromacrogol and cyanoacrylate used, directly correlated with the size of the varix. Multiple injection sites were chosen in attempt to obliterate the varix or varices in one session. Volume of lauromacrogol used ranged from 2-10ml, while that of cyanoacrylate ranged from 0.5-2ml, per injection site.
    Primary Outcome Measure Information:
    Title
    Rate of rebleeding
    Description
    New onset of hematemesis, coffee-ground vomitus, hematochezia,or melena,with an increasing pulse rate over 100 beats/min and decreasing blood pressure below 90 mmHg after a 24-hour period of stable vital signs and hemoglobin after endoscopic treatment.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Rate of GV eradication
    Description
    non-visualization of patent GV
    Time Frame
    6 months
    Title
    Incidence of complications
    Description
    Huge ulcer on GV, spontaneous bacterial peritonitis, bacteremia
    Time Frame
    6 months
    Title
    mortality
    Description
    Survival situation of patience
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 18 years of age;Past history of gastroesophageal variceal hemorrhage confirmed by an endoscopic examination Exclusion Criteria: Patients who are not suitable for endoscopic treatment judged by the clinician; Patients who are not suitable for the ligation treatment because of scar change by repeated glue injection; Patients with acute hemorrhage

    12. IPD Sharing Statement

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    Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices

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