Endoscopic Variceal Ligation in Children (NCT03943784) | Clinical Trial Compass
CompletedNot Applicable
Endoscopic Variceal Ligation in Children
60 participantsStarted 2014-01-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
2
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)