---
title: "Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol."
nct_id: NCT01196481
overall_status: COMPLETED
phase: NA
sponsor: Institute of Liver and Biliary Sciences, India
study_type: INTERVENTIONAL
primary_condition: Cirrhosis
countries: India
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01196481.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01196481"
ct_last_update_post_date: 2020-05-15
last_seen_at: "2026-05-12T06:30:11.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Carvedilol + VSL#3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.

**Official Title:** A Prospective,Open Labeled, Randomized Controlled Trial Comparing Carvedilol + VSL# 3 Versus Endoscopic Variceal Ligation for Primary Prophylaxis of Esophageal Variceal Bleeding in Cirrhotic Patients Non Responder to Carvedilol.

**NCT ID:** [NCT01196481](https://clinicaltrials.gov/study/NCT01196481)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 40
- **Lead Sponsor:** Institute of Liver and Biliary Sciences, India
- **Conditions:** Cirrhosis
- **Start Date:** 2012-12
- **Completion Date:** 2015-08
- **CT.gov Last Update:** 2020-05-15

## Brief Summary

Patients of cirrhosis will be enrolled who have large esophageal varices, which have never bled. After successful screening baseline hepatic venous pressure gradient (HVPG) will be measured. Tablet carvedilol 3.125 mg BD for 1 week will be started. It will be increased to 6.25 mg BD and continued for next 7 weeks. After completion of 8 weeks the hepatic venous pressure gradient (HVPG) will again be measured to find out responders (hepatic venous pressure gradient ≥20% reduction from baseline or absolute value of hepatic venous pressure gradient \<12 mm Hg) and non responders (hepatic venous pressure gradient \<20% reduction).The responders will be excluded from the study while the non responders will be randomize into carvedilol+VSL#3 versus Endoscopic Variceal Ligation.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients of cirrhosis with portal hypertension aged 18 to 75 years who have large esophageal varices with or without red color signs and have not bled previously.

Exclusion Criteria:

* Any contra-indication to beta-blockers
* Coagulopathy with INR \>1.8 at the time of enrollment
* Any Endoscopic Variceal Ligation or sclerotherapy within last 3 months
* Any past history of surgery for portal hypertension
* Significant cardio or pulmonary co-morbidity
* Any malignancy
* Refusal to participate in the study
```

## Arms

- **Carvedilol+VSL#3** (EXPERIMENTAL) — Tablet Carvedilol 6.25 mg BD + VSL#3
- **Endoscopic Variceal Ligation** (ACTIVE_COMPARATOR) — Endoscopic Variceal Ligation every 3-4 weeks till variceal ligation

## Interventions

- **Carvedilol+VSL#3** (DRUG) — Tablet Carvedilol 6.25 mg BD \& capsule VSL#3 1 TDS for 2 year
- **Endoscopic variceal ligation** (PROCEDURE) — In the Endoscopic Variceal Ligation arm, Endoscopic Variceal Ligation will be performed using multibander devices by senior fully trained endoscopists or under their direct supervision. Varices will be banded starting at the gastroesophageal junction moving proximally upward in a spiral fashion. Patients will undergo Endoscopic Variceal Ligation every 3-4 weeks until eradication. Eradication is defined as the absence of varices or presence of grade I esophageal varices. Following eradication, the interval for the next endoscopy will be every 3 months to look for recurrence of varices. Endoscopic Variceal Ligation sessions would be repeated for the recurrent varices if they are sufficiently large.

## Primary Outcomes

- **Development of first variceal bleeding** _(time frame: 1 Year)_

## Secondary Outcomes

- **Survival** _(time frame: 1 Year)_
- **Reduction in Portal pressure** _(time frame: 1 Year)_
- **Time to bleed** _(time frame: 1 Years)_
- **Adverse events** _(time frame: 1 Year)_

## Locations (1)

- Institute of Liver & Biliary Sciences (ILBS), New Delhi, National Capital Territory of Delhi, India

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.institute of liver & biliary sciences (ilbs)|new delhi|national capital territory of delhi|india` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01196481.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01196481*  
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