- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03943784
Endoscopic Variceal Ligation in Children
Endoscopic Variceal Ligation as Primary Prophylaxis for Upper Gastrointestinal Bleeding in Children
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients that present the first episode of Upper Gastrointestinal Bleeding after the use of endoscopic variceal ligation as a prophylactic treatment (Efficacy)
Time Frame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
|
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)
Time Frame: From the moment the patients received the endoscpoic variceal ligation to the end of the follow-up (April 2019)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survival at 1 year after prophylactic treatment (endoscopic or propranolol)
Time Frame: Survival will be reported at 1 year after the start of the prophylactic treatment
|
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
|
Survival at 3 year after prophylactic treatment (endoscopic or propranolol)
Time Frame: Survival will be reported at 3 years after the start of the prophylactic treatment
|
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
|
Transplant-free survival at 1 year
Time Frame: Transplant-free survival wil be reported at 1 year after the start of the prophylactic treatment
|
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
|
Transplant-free survival at 3 years
Time Frame: Transplant-free survival wil be reported at years after the endoscopic prophylaxis
|
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
|
Esophageal varices eradication with endoscopic treatment
Time Frame: From the first episode of variceal ligation to eradication
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Gastrointestinal Diseases
- Liver Diseases
- Fibrosis
- Esophageal Diseases
- Hypertension, Portal
- Hemorrhage
- Liver Cirrhosis
- Esophageal and Gastric Varices
- Gastrointestinal Hemorrhage
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Propranolol
- Adrenergic beta-Antagonists
Other Study ID Numbers
- 31/2019
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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