Endoscopic Variceal Ligation in Children

Child Clinical Trial

Official title:

Endoscopic Variceal Ligation as Primary Prophylaxis for Upper Gastrointestinal Bleeding in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03943784
• Other study ID #: 31/2019
• Status: Completed
• Start date: January 1, 2014
• Est. completion date: April 30, 2019

Study information

• Verified date: May 2019
• Source: Hospital Vall d'Hebron
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Child
• Endoscopy
• Esophageal and Gastric Varices
• Esophageal Varices in Cirrhosis of the Liver
• Gastrointestinal Hemorrhage
• Hemorrhage
• Liver Cirrhosis
• Upper Gastrointestinal Bleeding

Intervention

Procedure:
• Endoscopic Variceal Ligation
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.

Drug:
• Non-Selective Beta-Blocking Agent
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Vall d'Hebron

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
Primary	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	From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
Secondary	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	Survival will be reported at 1 year after the start of the prophylactic treatment
Secondary	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	Survival will be reported at 3 years after the start of the prophylactic treatment
Secondary	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	Transplant-free survival wil be reported at 1 year after the start of the prophylactic treatment
Secondary	Transplant-free survival at 3 years	Transplant-free survival was defined as the time from endoscopic variceal ligation or propranolol star to the date of transplantation, measured in months	Transplant-free survival wil be reported at years after the endoscopic prophylaxis
Secondary	Esophageal varices eradication with endoscopic treatment	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.	From the first episode of variceal ligation to eradication