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
About this trial
This is an interventional prevention trial for Gastroesophageal Varices
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
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
NCT ID
NCT03729921
First Posted
October 31, 2018
Last Updated
November 1, 2018
Sponsor
Shanghai Zhongshan Hospital
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
Learn more about this trial
Gastric Variceal Ligation Versus Gastric Variceal Obturation for Secondary Prophylaxis of Gastric Varices
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