Radical Versus Conservative Surgery in Liver Cystic Echinococcosis: a Prospective Cohort Study in a High-volume Western Centre
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors
研究概览
简要总结
The goal of this observational study is to compare the results in terms of morbidity and disease-free survival between groups of patients with liver cystic echinococcosis (LCE) managed with radical surgery (RS) or conservative surgery (CS), and to evaluate potential risk factors of clinically relevant biliary fistula and liver recurrence.
详细描述
Main hypothesis:
- Radical surgery (RS) in LCE has better postoperative results than conservative surgery (CS) in terms of global morbidity, specific morbidity and liver recurrence rate.
Secondary hypotheses: 2. It is possible to identify preoperative and intraoperative prognostic factors of higher morbidity and recurrence rate. 3. The location of the residual pericystic layer in CS is related to a higher incidence of liver recurrence. 4. The percentage of residual pericystic layer in CS is related to a higher incidence of postoperative biliary fistula.
Main outcome:
- To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors.
- To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult population (18 years or older) of both sexes surgically intervened for a diagnosis of LCE at the Bellvitge University Hospital and during the period described using a conservative or radical technique.
- •Patients with asymptomatic liver hydatid cysts of active type or transition CE1 to CE3 according to the WHO classification.
- •Patients with symptomatic or complicated hepatic hydatid cysts of any type (CE1 to CE5) according to the WHO classification.
排除标准
- •Patients under 18 years of age.
- •Patient operated on for LCE diagnosis with inactive asymptomatic cysts (CE4 or CE5 according to the WHO classification).
- •Patients with less than 1 year of follow-up.
结局指标
主要结局
To assess the incidence of liver recurrence between the RS and the CS groups, identifying potential risk factors
时间窗: Diagnosis during the first 6 months was considered as persistence of the disease.
Hepatic recurrence was defined as the appearance of a new growing cyst, non-detected by radiologic exploration before the first surgery, in the first location of the hydatid cyst in the liver or in another liver's segment.
To evaluate the incidence of postoperative biliary fistula between the RS and the CS groups, identifying possible risk factors.
时间窗: 90 days postoperative
The type of fistula was classified according to the International Study Group of Liver Surgery classification. A complex biliary fistula was defined as external bile leakage for ≥28 days and/or the need for percutaneous drainage or reoperation.
次要结局
- To specifically analyze the incidence of postoperative biliary fistula and complex biliary fistula, and identify possible risk factors.(90 days postoperative)
- To estimate the incidence of overall morbidity related to surgery.(90 days postoperative)
- To estimate the rate of hepatic and extrahepatic recurrence (number of disease-free months)(From 6 months postoperative)
- To estimate the incidence of specific morbidity related to surgery.(90 days postoperative)
- To estimate the incidence of mortality related to surgery.(90 days postoperative)
研究者
Marina Vila Tura
Marina Vila Tura, MD
Hospital Universitari de Bellvitge