Endoscopic Variceal Ligation in Children

NCT03943784 | Completed

• 1 other identifier: 31/2019
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (5)

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

  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 will be reported at 3 years after the start of the prophylactic treatment

• Transplant-free survival at 1 year

  Transplant-free survival wil be reported at 1 year after the start of the prophylactic treatment

• Transplant-free survival at 3 years

  Transplant-free survival wil be reported at years after the endoscopic prophylaxis

• Esophageal varices eradication with endoscopic treatment

  From the first episode of variceal ligation to eradication

Study Arms (2)

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.

Procedure: Endoscopic Variceal Ligation

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.

Drug: Non-Selective Beta-Blocking Agent

Interventions

Endoscopic Variceal Ligation 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.

Endoscopic Variceal Ligation

Non-Selective Beta-Blocking Agent 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.

Also known as: Propranolol

Propranolol Group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Vall d'Hebron: lead

Related Publications (1)

• 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.

  PMID: 32119939 DERIVED

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible of Pediatric Hepatology and Liver Transplant Department

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 9, 2019
• Study Start: January 1, 2014
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 9, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share