Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy

April 9, 2022 updated by: GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy for the Control of Acute Variceal Bleeding in Patients With Liver Cirrhosis at a Tertiary Center in Mexico

In the Western world, liver cirrhosis is a significant issue. Acute variceal bleeding (AVB) is a considerable complication of cirrhosis associated with high mortality. Still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. This therapy with terlipressin usually was used for 72 hours. However, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the Western world, liver cirrhosis is a significant issue. Acute variceal bleeding (AVB) is a considerable complication of cirrhosis associated with high mortality. Still, the combination of endoscopic variceal ligation and terlipressin-like treatment decreases the risks of rebleeding and mortality. This therapy with terlipressin usually was used for 72 hours. However, there are some studies demostrating that using terlipressin for 24 hours could control variceal bleeding with fewer side effects.

Objective: To compare endoscopic band ligation plus terlipressin for 24 vs 72 hours during acute variceal bleeding in liver cirrhosis.

Study Type

Interventional

Enrollment (Actual)

109

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44329
        • Centro Médico Nacional de Occidente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of 18 years and older
  • Both genders,
  • Diagnosis of liver cirrhosis with a Child-Pugh score ≤ 11 (class B or C)
  • Acute variceal bleeding were included

Exclusion Criteria:

  • Patients with contraindications to terlipressin (pregnancy, breastfeeding, or severe cardiopulmonary diseases),
  • Presence of sepsis,
  • Multi-organ failure,
  • The requirement of continuous ionotropic or ventilatory support,
  • Bleeding disorders,
  • Hepatocellular carcinoma or other extrahepatic malignanc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 24-h group
The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.
Combination product: banding ligation plus terlipressin infusion
Subjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy. The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe. The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.
Active Comparator: 72-h group
The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe
Combination product: banding ligation plus terlipressin infusion
Subjects were randomly allocated to banding ligation plus terlipressin infusion for 24 hours (24-h group) or banding ligation plus terlipressin infusion for 72 hours (72-h group) using a blocked allocation strategy. The 72-h group received the standard treatment with administration of intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) with an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 72 hours. Terlipressin was administered blinded after endoscopic treatment and infused as a 5 ml bolus in a pre-prepared syringe. The 24-h group received intravenous terlipressin (Glypressin® Ferring Pharmaceuticals) as an initial intravenous bolus of 2 mg (10 ml) and thereafter every 6 hours for a period of 24 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the 24-h group vs 72-h group
Time Frame: The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event
Differences between groups at baseline were evaluated with Student's t-test test for continuous variables and proportions were compared using the Chi2 or Fisher test.
The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Principal Investigator: Alejandro González-Ojeda, Instituto Mexicano del Seguro Social

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

March 29, 2022

First Submitted That Met QC Criteria

April 9, 2022

First Posted (Actual)

April 18, 2022

Study Record Updates

Last Update Posted (Actual)

April 18, 2022

Last Update Submitted That Met QC Criteria

April 9, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Terlipressin proyect

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is expected to find a journal that is interested in our research and that is open access

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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