Clinical trial NCT03943784: Endoscopic Variceal Ligation in Children
Official title: Endoscopic Variceal Ligation as Primary Prophylaxis for Upper Gastrointestinal Bleeding in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Esophageal Varices in Cirrhosis of the Liver
Upper Gastrointestinal Bleeding
Endoscopy
Child
Lead sponsor: Hospital Vall d'Hebron
Sponsor class: OTHER
First posted: 2019-05-09
Enrollment: 60
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pediatric patients with a known chronic liver disease with suspicion of portal hypertension who presented grade 2 or 3 esophageal varices or red spots, regardless of the grade of the esophageal varices diagnosed by endoscopy from January 2009 to April 2017 that received propranolol or endoscopic variceal ligation as a primary prophylaxis.

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.

Eligibility 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.

Primary outcomes:
measure: Number of patients that present the first episode of Upper Gastrointestinal Bleeding after the use of endoscopic variceal ligation as a prophylactic treatment (Efficacy)
timeFrame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
measure: Number of patients that present adverse events related to the use of endoscopic variceal ligation as a prophylactic treatment (Safety)
timeFrame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
Secondary outcomes:
measure: Survival at 1 year after prophylactic treatment (endoscopic or propranolol)
timeFrame: Survival will be reported at 1 year after the start of the prophylactic treatment
measure: Survival at 3 year after prophylactic treatment (endoscopic or propranolol)
timeFrame: Survival will be reported at 3 years after the start of the prophylactic treatment
measure: Transplant-free survival at 1 year
timeFrame: Transplant-free survival wil be reported at 1 year after the start of the prophylactic treatment
measure: Transplant-free survival at 3 years
timeFrame: Transplant-free survival wil be reported at years after the endoscopic prophylaxis
measure: Esophageal varices eradication with endoscopic treatment
timeFrame: From the first episode of variceal ligation to eradication
Other outcomes:
Locations:
Study officials:
References:
citation: Quintero J, Juamperez J, Mercadal-Hally M, King ML, Ortega J, Molino JA, Abu-Suboh M, Dot J, Nuno R, Montferrer N, Armengol JR, Charco R. Endoscopic variceal ligation as primary prophylaxis for upper GI bleeding in children. Gastrointest Endosc. 2020 Aug;92(2):269-275. doi: 10.1016/j.gie.2020.02.035. Epub 2020 Feb 29.