Endoscopic Variceal Ligation as Primary Prophylaxis for Upper Gastrointestinal Bleeding in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Number of patients that present adverse events related to the use of endoscopic variceal ligation as a prophylactic treatment (Safety)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
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.
干预措施: Endoscopic Variceal Ligation (Procedure)
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.
干预措施: Non-Selective Beta-Blocking Agent (Drug)
结局指标
主要结局
Number of patients that present adverse events related to the use of endoscopic variceal ligation as a prophylactic treatment (Safety)
时间窗: 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
Number of patients that present the first episode of Upper Gastrointestinal Bleeding after the use of endoscopic variceal ligation as a prophylactic treatment (Efficacy)
时间窗: 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
次要结局
- Survival at 1 year after prophylactic treatment (endoscopic or propranolol)(Survival will 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)
- 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)
研究者
Jesús Quintero
Responsible of Pediatric Hepatology and Liver Transplant Department
Hospital Vall d'Hebron