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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05331768
Recruitment Status : Completed
First Posted : April 18, 2022
Last Update Posted : April 18, 2022
Sponsor:
Information provided by (Responsible Party):
GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social

Study Description
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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.

Condition or disease Intervention/treatment Phase
Esophageal and Gastric Varices Combination Product: banding ligation plus terlipressin infusion Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 109 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (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
Primary Purpose: Treatment
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
Actual Study Start Date : January 1, 2021
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05331768


Locations
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Mexico
Centro Médico Nacional de Occidente
Guadalajara, Jalisco, Mexico, 44329
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
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Principal Investigator: Alejandro González-Ojeda Instituto Mexicano del Seguro Social
More Information
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Publications of Results:

Other Publications:

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Responsible Party: GONZALEZ-OJEDA ALEJANDRO, Clinical Professor, Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier: NCT05331768    
Other Study ID Numbers: Terlipressin proyect
First Posted: April 18, 2022    Key Record Dates
Last Update Posted: April 18, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is expected to find a journal that is interested in our research and that is open access

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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
Keywords provided by GONZALEZ-OJEDA ALEJANDRO, Instituto Mexicano del Seguro Social:
Terlipressin
Liver Cirrhosis
Esophageal and Gastric Varices,
Collateral Circulations
Additional relevant MeSH terms:
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Esophageal and Gastric Varices
Liver Diseases
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
 Hypertension, Portal
Terlipressin
Antihypertensive Agents
Vasoconstrictor Agents