Clinical trial NCT05331768: 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
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal and Gastric Varices
Keywords: Terlipressin
Liver Cirrhosis
Esophageal and Gastric Varices,
Collateral Circulations
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2022-04-18
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Compare the 24-h group vs 72-h group
timeFrame: The total study time ranges from the first day of telmipressin infusion to 6 weeks after the event
Secondary outcomes:
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Centro Médico Nacional de Occidente
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Alejandro González-Ojeda
role: PRINCIPAL_INVESTIGATOR
References:
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