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

NCT05331768 | Completed DMC

• 1 other identifier: Terlipressin proyect
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal and Gastric Varices

Keywords

Terlipressin; Liver Cirrhosis; Esophageal and Gastric Varices,; Collateral Circulations

Outcome Measures

Primary Outcomes (1)

• 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.

  The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event

Study Arms (2)

24-h group

EXPERIMENTAL

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

72-h group

ACTIVE COMPARATOR

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

Interventions

banding ligation plus terlipressin infusion COMBINATION_PRODUCT

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.

24-h group; 72-h group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Mexicano del Seguro Social: lead

Study Sites (1)

Centro Médico Nacional de Occidente

Guadalajara, Jalisco, 44329, Mexico

Location

Related Publications (21)

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  PMID: 25920090 RESULT

MeSH Terms

Conditions

Esophageal and Gastric Varices; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hypertension, Portal; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alejandro González-Ojeda

  Instituto Mexicano del Seguro Social

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: 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

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 18, 2022
• Study Start: January 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 18, 2022

Record last verified: 2022-04

Locations

ME (1)