A study to assess the Comparison between Endoscopic Ultrasound-Guided Coil and n-butyl cyanoacrylate glue versus radiological intervention in preventing rebleeding in patients with gastric varices
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2022/10/046363
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Cirrhosis with acute variceal bleeding
2.GOV2 and IGV1
3.Age between 18-65 years
4.Willing to participate in the study
1.Variceal bleeding secondary to causes other than cirrhosis
2.Variceal bleeding from EV
3.Patients with malignancy/disseminated intravascular coagulation (DIC)/known coagulopathic disorder (hemophilia) apart from cirrhosis.
4.History of intake of platelets inhibitors (e.g., aspirin, clopidogrel) and drugs affecting coagulation cascade (e.g., vitamin K antagonists) within past 7 days
5.Pregnant women
6.History of underlying hypercoagulable/ hypocoagulable states e.g. paroxysmal nocturnal hemoglobinuria (PNH), and polycythemia vera.
7.Patients with refractory shock
8.Sepsis/ACLF
9.Contraindication to endoscopy
10.Not willing to provide consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.To compare the rebleed rate between the EUS-guided coil embolization with glue injection and glue and BRTO or TIPSS at 1 yearTimepoint: 1 year
- Secondary Outcome Measures
Name Time Method 1.All-cause mortality at 1 year <br/ ><br>2.Grade of esophageal varices at 1, 3, 6, and 12 months <br/ ><br>3.Complications and adverse events at 1, 3, 6, and 12 months <br/ ><br>Timepoint: 1. 1 Year <br/ ><br>2. 1,2,3,6, and 12 months <br/ ><br>3. 1,2,3,6, and 12 months