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

Recruiting

• Conditions: Other and unspecified cirrhosis ofliver,

• Registration Number: CTRI/2022/10/046363
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Portalhypertension (PHT) is a major consequence of cirrhosis and is responsible forits most severe complications leading to increased morbidity and mortality,including bleeding from gastroesophageal varices. The most common cause ofbleeding in cirrhosis is bleeding from esophageal varices (EVs), followed bygastric varices (GVs).  GVs are lesscommon (20%) and have a lower bleeding risk. Compared to EVs bleeding, GVbleeding is massive, requires more blood transfusions, and has highermortality.

The1-year risk of GV bleeding is 10%–16%[2–5].  The cumulative risk forGV hemorrhage at 1, 3, and 5 years is 16%, 36%, and 44%, respectively. In contrast to EVs, GVs bleedat lower portal pressure and do not correlate with hepatic venous pressure gradient(HVPG). Due to this, medical therapy forlowering portal pressure is not beneficial in managing GV. The treatment of GVs is notwell standardized compared to EVs, where the primary prophylaxis, secondaryprophylaxis, and treatment are well established.

The most common and easily available treatmentof GV is n-butyl cyanoacrylate glue injection. The risk of rebleed andmortality after glue therapy is 15% and 3% in a randomized control trial duringa median follow-up of 26 months, respectively. Complications due to glue injection includeembolization of the glue thrombus, exacerbation of bleeding, and impaction ofthe needle into the GV, portal vein thrombosis, and infection. The most feared complication is glue pulmonaryembolism; however, the largest series documented that the clinically significantsystemic embolic events rate was 0.7%. Other complications are very rare.

Itis clear that if GV rebleed, treatment options are BRTO, TIPSS and EUS-guidedcoil embolization, but which one is better is not clear. Therefore in this RCT,we will compare the efficacy and safety of EUS-guided coil embolization withglue injection and balloon-occluded retrograde transvenous obliteration (BRTO)to prevent rebleeding in patients with cirrhosis and GVs after primaryhemostasis.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-17
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Cirrhosis with acute variceal bleeding 2.GOV2 and IGV1 3.Age between 18-65 years 4.Willing to participate in the study.

Exclusion Criteria

• 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 year	1 year

Secondary Outcome Measures

Name	Time	Method
1.All-cause mortality at 1 year	2.Grade of esophageal varices at 1, 3, 6, and 12 months

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 West, DELHI, India

All India Institute of Medical Sciences

🇮🇳West, DELHI, India

Dr Deepak Gunjan

Principal investigator

9811225431

deepakgunjan31@gmail.com