Comparison of n-butyl cyanoacrylate glue alone versus n-butyl cyanoacrylate glue plus radiological intervention in preventing rebleeding in patients with gastric varices
- Conditions
- Health Condition 1: K922- Gastrointestinal hemorrhage, unspecified
- Registration Number
- CTRI/2021/02/031396
- Lead Sponsor
- Dr Shalimar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.All patients with upper GI bleed originating from GOV-2/IGV-1, seen on endoscopy
2.Age between 18-65 years
3.Willing to participate in the study
1.Failure to control bleed or early rebleed
2.Non-cirrhotic causes of portal hypertension
3.Hepatocellular carcinoma
4.Portal vein thrombosis/Portal cavernoma
5.Contraindications to beta-blockers
6.Active sepsis with or without septic shock
7.Underlying cardiopulmonary disease
8.Prior glue/TIPSS/BRTO
9.Chronic Kidney Disease or Acute kidney injury with Creatinine >1.5
10.HE grade 1 and above/or past history of HE
11.Pregnant females
12.MELD >20
13.Acute on chronic liver failure as defined by EASL criteria
14.Death within 72 hours of admission
15.Biliary malignancy
16.Denied consent for participation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Comparison of GV rebleed rates between the 2 groups (Glue alone vs glue plus radiological intervention)Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method All cause rebleeding ratesTimepoint: 12 months;Amount of glue and sessions of endoscopy for GV obliterationTimepoint: 1,3,6 and 12 months;Assessment of complication rates- ulcer formation/embolism/ascites/HETimepoint: 1, 3, 6 and 12 months.;Assessment of technical successTimepoint: At baseline;Change in liver function (MELD and CTP)Timepoint: 1, 3, 6 and 12 months;Number and duration of hospitalizationsTimepoint: 1,3,6 and 12 months;Overall and GV bleed related mortalityTimepoint: 1, 3, 6, and 12 months;Overall Cost of the proceduresTimepoint: At baseline;Rate of aggravation of esophageal varicesTimepoint: 1,3,6 and 12 months;Rate of GV obliterationTimepoint: 1,3,6 and 12 months