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

Primary Purpose

Esophageal and Gastric Varices

Status
Completed
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
banding ligation plus terlipressin infusion
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal and Gastric Varices focused on measuring Terlipressin, Liver Cirrhosis, Esophageal and Gastric Varices,, Collateral Circulations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centro Médico Nacional de Occidente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

24-h group

72-h group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Compare the 24-h group vs 72-h group
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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2022
Last Updated
April 9, 2022
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT05331768
Brief Title
Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal and Gastric Varices
Keywords
Terlipressin, Liver Cirrhosis, Esophageal and Gastric Varices,, Collateral Circulations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was a randomized clinical trial. Eligible patients were randomised to receive banding ligation plus terlipressin infusion for 24 hours or banding ligation plus terlipressin infusion for 72 hours
Masking
Participant
Masking Description
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
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
24-h group
Arm Type
Experimental
Arm Description
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.
Arm Title
72-h group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
banding ligation plus terlipressin infusion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Compare the 24-h group vs 72-h group
Description
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.
Time Frame
The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro González-Ojeda
Organizational Affiliation
Instituto Mexicano del Seguro Social
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Médico Nacional de Occidente
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44329
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
It is expected to find a journal that is interested in our research and that is open access
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Comparison of Endoscopic Band Ligation Plus 24-hour Versus 72-hour Terlipressin Therapy

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