Endoscopic Variceal Ligation in Children

Completed

• Conditions: Upper Gastrointestinal Bleeding; Endoscopy; Child; Esophageal Varices in Cirrhosis of the Liver
• Interventions: Drug: Non-Selective Beta-Blocking Agent; Procedure: Endoscopic Variceal Ligation

• Registration Number: NCT03943784
• Lead Sponsor: Hospital Vall d'Hebron

Brief Summary

This is an ambispective single-center cohort study of pediatric patients with portal hypertension and esophageal varices. The study was designed to evaluate the efficacy and safety of primary prophylaxis with endoscopic variceal ligation to prevent upper gastrointestinal bleeding compared to non-selected beta-blockers prophylaxis.

Detailed Description

Endoscopic Variceal Ligation group; Inclusion criteria From January 2014 to April 2017, a study group was created, including all paediatric patients with a known chronic liver disease with suspicion of portal hypertension and grade 2 or 3 OV or red spots, regardless of the grade of the OV diagnosed by endoscopy.

Propanolol group Patients in the Endoscopic Variceal Ligation study group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices in the upper endoscopy, who received propranolol as primary prophylaxis from January 2009 to December 2013.

Ligation sessions were performed every 6 weeks until varices eradication. When eradication was achieved, upper endoscopy was performed at 2 and 6 months to assess the efficacy of the treatment. If no varices were observed, upper endoscopies were performed once a year thereafter.

Eradication was defined as disappearance of all varices or reduction to grade 1 small varices without reddish spots and no gastric varices.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-08
• Last Update Submitted: 2019-05-08
• Study First Posted: 2019-05-09
• Last Update Posted: 2019-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propranolol Group	Non-Selective Beta-Blocking Agent	Patients in the Endoscopic Variceal Ligation group were compared with an historical cohort of 30 consecutive patients with portal hypertension and grade 2 or 3 esophageal varices or red spots who received propranolol as primary prophylaxis from January 2009 to December 2013. All patients were treatment-naïve in regards of their upper gastrointestinal bleeding prophylaxis at the time of the first upper endoscopy.
Endoscopic Variceal Ligation	Endoscopic Variceal Ligation	From January 2014 to April 2017, all paediatric patients with a known chronic liver disease with suspicion of portal hypertension who presented grade 2 or 3 esophageal varices or red spots in the upper endoscopy received primary prophylaxis with endoscopic variceal ligation.

Primary Outcome Measures

Name	Time	Method
Number of patients that present adverse events related to the use of endoscopic variceal ligation as a prophylactic treatment (Safety)	From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)	Hematology and biochemistry parameters and adverse events notified during the study will be recorded in order to evaluate the safety and tolerability of endoscopic variceal ligation as prophylactic treatment of upper gastrointestinal bleeding in pediatric patients
Number of patients that present the first episode of Upper Gastrointestinal Bleeding after the use of endoscopic variceal ligation as a prophylactic treatment (Efficacy)	From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)	From the moment that the endoscopic variceal ligation was performed, the number of patients that present the first episode of upper gastrointestinal bleeding due to esophageal varices will be recorded

Secondary Outcome Measures

Name	Time	Method
Survival at 1 year after prophylactic treatment (endoscopic or propranolol)	Survival will be reported at 1 year after the start of the prophylactic treatment	Survival was defined as the time from endoscopic variceal ligation/propranolol start to death due to upper gastrointestinbal bleeding or date of last follow-up, measured in months
Transplant-free survival at 3 years	Transplant-free survival wil be reported at years after the endoscopic prophylaxis	Transplant-free survival was defined as the time from endoscopic variceal ligation or propranolol star to the date of transplantation, measured in months
Esophageal varices eradication with endoscopic treatment	From the first episode of variceal ligation to eradication	The number of patients that present esophageal varices eradication using endoscopic variceal ligation. Eradication was defined as disappearance of all varices or reduction to grade 1 small varices without reddish spots and no gastric varices.
Survival at 3 year after prophylactic treatment (endoscopic or propranolol)	Survival will be reported at 3 years after the start of the prophylactic treatment	Survival was defined as the time from endoscopic variceal ligation/propranolol start to death due to upper gastrointestinbal bleeding or date of last follow-up, measured in months
Transplant-free survival at 1 year	Transplant-free survival wil be reported at 1 year after the start of the prophylactic treatment	Transplant-free survival was defined as the time from endoscopic variceal ligation or propranolol start to the date of transplantation, measured in months