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

Not Applicable

Completed

• Conditions: Esophageal and Gastric Varices
• Interventions: Combination Product: banding ligation plus terlipressin infusion

• Registration Number: NCT05331768
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Study First Submitted: 2022-03-29
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-09
• Last Update Submitted: 2022-04-09
• Study First Posted: 2022-04-18
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24-h group	banding ligation plus terlipressin infusion	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.
72-h group	banding ligation plus terlipressin infusion	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

Primary Outcome Measures

Name	Time	Method
Compare the 24-h group vs 72-h group	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.

Trial Locations

Locations (1)

Centro Médico Nacional de Occidente; 🇲🇽 Guadalajara, Jalisco, Mexico