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

Instituto Mexicano del Seguro Social

Status: Completed

Conditions: Esophageal and Gastric Varices

Treatments: Combination Product: banding ligation plus terlipressin infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT05331768

Terlipressin proyect

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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109 participants in 2 patient groups

24-h group

Experimental group

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.

Treatment:

Combination Product: banding ligation plus terlipressin infusion

72-h group

Active Comparator group

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

Treatment:

Combination Product: banding ligation plus terlipressin infusion