search
Back to results

Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis (Secondary)

Primary Purpose

Portal Hypertension

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
EVL + Propranolol + Isosorbide 5 mononitrate
EVL alone
Sponsored by
Govind Ballabh Pant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Portal Hypertension

Eligibility Criteria

8 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting to G B Pant Hospital, New Delhi, with history of hematemesis and/or melena and proven to have esophageal varices as the bleeding source on upper GI endoscopy were included in the study.

Exclusion Criteria:

  • A history of undergoing endoscopic sclerotherapy (EST), EVL, or cyanoacrylate injection;
  • A history of surgery for portal hypertension;
  • Coexisting malignancy;
  • Severe cardiopulmonary or renal disease;
  • A history of severe side-effects or contraindications to beta-blockers like bronchial asthma, uncontrolled diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, arterial hypotension (systolic blood pressure < 100 mm Hg), bradycardia (basal heart rate <55 beats per minute), or complete heart block; and
  • Refusal to give consent to participate in the trial.

Sites / Locations

  • Department of Gastroenterology, G B Pant Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EVL + Drugs

EVL alone

Arm Description

Patients randomized to the EVL plus drugs therapy received EVL plus beta-blocker (propranolol) and nitrate (ISMN).

Patients assigned to the EVL group underwent variceal band ligation alone till variceal obliteration.

Outcomes

Primary Outcome Measures

Primary end points of the study were bleeding and death.

Secondary Outcome Measures

Complications, UGI bleeding due to causes not related to PHT, and adverse effects that required the discontinuation of therapy.

Full Information

First Posted
October 3, 2008
Last Updated
October 3, 2008
Sponsor
Govind Ballabh Pant Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00766805
Brief Title
Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis
Acronym
Secondary
Official Title
Endoscopic Variceal Ligation Plus Propranolol And Isosorbide Mononitrate Versus Endoscopic Variceal Ligation Alone For Secondary Prophylaxis Of Variceal Bleeding: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Govind Ballabh Pant Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure reducing drugs should significantly be better than EVL alone. Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included complications of portal hypertension and the development of serious adverse effects to therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
177 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EVL + Drugs
Arm Type
Active Comparator
Arm Description
Patients randomized to the EVL plus drugs therapy received EVL plus beta-blocker (propranolol) and nitrate (ISMN).
Arm Title
EVL alone
Arm Type
Placebo Comparator
Arm Description
Patients assigned to the EVL group underwent variceal band ligation alone till variceal obliteration.
Intervention Type
Drug
Intervention Name(s)
EVL + Propranolol + Isosorbide 5 mononitrate
Intervention Description
Treatment was started with propranolol at a dose of 40 mg twice a day. The heart rate and blood pressure were checked after 12 to 24 hours. The dose of propranolol was increased at increments of 20 to 40 mg per day until the patient achieved a heart rate of 55 bpm, or a maximum dose of 320 mg/day was achieved.ISMN was added at a dose of 10 mg twice a day. The dose was escalated at increments of 10-20 mg/day till a maximum dose of 40 mg/day was reached.
Intervention Type
Other
Intervention Name(s)
EVL alone
Primary Outcome Measure Information:
Title
Primary end points of the study were bleeding and death.
Time Frame
During the study period
Secondary Outcome Measure Information:
Title
Complications, UGI bleeding due to causes not related to PHT, and adverse effects that required the discontinuation of therapy.
Time Frame
During the study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients presenting to G B Pant Hospital, New Delhi, with history of hematemesis and/or melena and proven to have esophageal varices as the bleeding source on upper GI endoscopy were included in the study. Exclusion Criteria: A history of undergoing endoscopic sclerotherapy (EST), EVL, or cyanoacrylate injection; A history of surgery for portal hypertension; Coexisting malignancy; Severe cardiopulmonary or renal disease; A history of severe side-effects or contraindications to beta-blockers like bronchial asthma, uncontrolled diabetes mellitus, heart failure, peripheral vascular disease, prostatic hypertrophy, arterial hypotension (systolic blood pressure < 100 mm Hg), bradycardia (basal heart rate <55 beats per minute), or complete heart block; and Refusal to give consent to participate in the trial.
Facility Information:
Facility Name
Department of Gastroenterology, G B Pant Hospital
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110002
Country
India

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis

We'll reach out to this number within 24 hrs