Endoscopic Variceal Ligation in Children

NCT ID: NCT03943784

Last Updated: 2019-05-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-01
• Study Completion Date: 2019-04-30

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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.

Endoscopic Variceal Ligation

Intervention Type: PROCEDURE

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.

Propranolol Group

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.

Non-Selective Beta-Blocking Agent

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

Other Intervention Names

Propranolol

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• 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.

• Patients initially treated with non-selective beta blockers and subsequently treated with endoscopic variceal ligation as primary prophylaxis were excluded of the study.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Vall d'Hebron

OTHER

Sponsor Role: lead

Responsible Party

Jesús Quintero

Responsible of Pediatric Hepatology and Liver Transplant Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 32119939 (View on PubMed)

Other Identifiers

31/2019

Identifier Type: -

Identifier Source: org_study_id