Efficacy Of A Removable Intraductal Stent In Duct-To-Duct Biliary Reconstruction To Prevent Biliary Complications In Liver Transplantation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 493
- 试验地点
- 1
- 主要终点
- Incidence of biliary strictures and biliary fistulae within six months post-transplantation.
研究概览
简要总结
Randomized controlled trial including 7 French transplantation centers. Pre-inclusion of the patients is made when enlisted for liver transplantation (LT). Definitive inclusion and randomization is performed during LT, for patients undergoing a duct-to-duct biliary anastomosis with a graft bile duct diameter smaller than 7mm. In the intraductal stent tube group, a custom-made segment of a T-tube is placed into the bile duct, and removed endoscopically four to six months postoperative. The surgical technique is available on a movie during randomization on the website. The primary endpoint is the occurrence of biliary complications, including biliary fistulae and strictures, during six months of follow-up. Secondary evaluation criteria are the incidence of complications related to the stent placement and its extraction by endoscopy.
Discussion: Biliary complications following LT are significant causes of morbidity, retransplantation and eventually mortality. Although controversial, the use of a T-tube has been proven to be useless and even responsible for specific complications in many studies, including several randomized trials. However, several studies have identified a small bile duct diameter as a risk factor for biliary stenosis. A threshold of 7mm was found to be significantly associated to biliary stenosis. Our team published a preliminary study including 20 patients using a new technique of intraductal stenting. Only 4 complications were reported in the overall study population while no biliary complication occurred in the subgroup of patients who received a whole graft LT. Moreover, no technical failure and no procedure-related complications were noted before and during drain removal. Although intraductal stent tube in duct-to duct biliary anastomosis seems feasible and safe, a multicentric randomized controlled study is needed to validate it as a protective tool for biliary complications following LT.
详细描述
Comparative, multicentric, prospective, randomized non-blinded, two-groups study.
The follow-up is set at six months postoperative for a good screening of the majority of biliary complications.
The inclusion period is set at 3.5 years, for total study duration of 4 years. The patients' inclusion will be made in 7 liver transplantation centers in France.
Patients' inclusion will be performed in consultation at the moment of enlistment for LT, where they will be informed of the content, the benefits and risks of the study, and have to sign a written consent.
Definitive inclusion will be performed in operating room, during LT, and depends on fulfilling of the following "definitive inclusion criteria" (see above).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Patients eligible for a liver transplantation
- •Patients' written informed consent signed
- •Patient with social coverage (excepting AME)
- •Exclusion criteria:
- •Biliary reconstruction decided to be a hepaticojejunostomy for anatomical/biliary disease reason
- •Non eligibility for liver transplantation:
- •Uncontrolled infectious process
- •Incompatible physical or mental state with the observance of the immunosuppressive drugs
- •Cardiopulmonary comorbidities severe / uncontrolled
- •Active alcohol intoxication or addiction
- •Pregnant or breastfeeding women (pregnancy test will be performed at baseline)
- •Latex Allergy, polymer or rubber
- •Patient participating in another interventional study about biliary disease
排除标准
- 未提供
结局指标
主要结局
Incidence of biliary strictures and biliary fistulae within six months post-transplantation.
时间窗: 6 months
A biliary leakage is defined by the presence of bile in the abdominal drainage, and/or an intra-abdominal collection with bilious content requiring drainage. A biliary stenosis is defined by a size discrepancy between the two sides of the bile duct anastomosis on specific imaging (MR cholangiography, ERCP), associated to an upstream bile tract distention, with a clinical and biological cholestasis, after excluding other cholestasis causes (rejection, viral reactivation).
次要结局
- Incidence of specific complications related to the IST and its extraction by endoscopy(6 months)
- Graft survival(6 months)
- Patient survival(6 months)