Endoscopic Variceal Ligation in Children

Hospital Vall d'Hebron60 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Esophageal Varices in Cirrhosis of the Liver Upper Gastrointestinal Bleeding Endoscopy Child

Interventions

Endoscopic Variceal LigationPROCEDURE

Endoscopic varices ligation was performed with a six-shooter multiband ligator (Cook Medical, Limerick, Ireland) if medium to large varices or reddish spots, regardless of the grade of the varix, were observed. Each varix was ligated 1-2 cm above the gastro-esophageal junction, with 1 or 2 rubber bands and using no more than 5 rubber bands per session.

Non-Selective Beta-Blocking AgentDRUG

Patients of the Propranolol group that presented medium to large esophageal varices without contraindication to Non-Selective Beta-Blockers, received propranolol, 1 mg/Kg/day every 8 hours, titrated to reduce the basal heart rate in 25% and not exceeding 5 mg/Kg/day. Patients were evaluated monthly until this reduction in heart rate was achieved, and every three to six months thereafter.

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria for endoscopic variceal ligation cohort * All paediatric patients (\< 18 years) * Known chronic liver disease * Suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (\<150.000 platelets/L), * Grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy * From January 2014 to April 2017 Exclusion Criteria for endoscopic variceal ligation cohort: * Patients initially treated with Non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study. * Patients for whom endoscopic variceal ligation was not feasible because of patients' weight/seize were also excluded of the study. Inclusion Criteria for propranolol cohort * All paediatric patients (\< 18 years) * Known chronic liver disease * Suspicion of portal hypertension based on splenomegaly in the ultrasound, presence of collaterals in the abdominal wall or low platelet count (\<150.000 platelets/L), * Grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy * That received propranolol as primary prophylaxis * From January 2009 to December 2013. Exclusion Criteria propranolol cohort: * Patients initially treated with non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.

Outcomes

Primary Outcomes

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 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

Time frame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)

Number of patients that present adverse events related to the use of endoscopic variceal ligation as a prophylactic treatment (Safety)

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

Time frame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)

Secondary Outcomes

Survival at 1 year after prophylactic treatment (endoscopic or propranolol)

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

Time frame: Survival will be reported at 1 year after the start of the prophylactic treatment

Survival at 3 year after prophylactic treatment (endoscopic or propranolol)

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

Time frame: Survival will be reported at 3 years after the start of the prophylactic treatment

Transplant-free survival at 1 year

Transplant-free survival was defined as the time from endoscopic variceal ligation or propranolol start to the date of transplantation, measured in months

Data from ClinicalTrials.gov

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