Endoscopic Variceal Ligation in Children

Catalan Institute of Health

Status: Completed

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

Treatments: Drug: Non-Selective Beta-Blocking Agent; Procedure: Endoscopic Variceal Ligation

Study type: Observational

Funder types: Other

Identifiers

NCT03943784

31/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

60 participants in 2 patient groups

Endoscopic Variceal Ligation

Description:

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.

Treatment:

Procedure: Endoscopic Variceal Ligation

Propranolol Group

Description:

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.

Treatment:

Drug: Non-Selective Beta-Blocking Agent