Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction: An Open-label, Multicenter Randomized Trial (CARPEDIEM Trial)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 120
- 试验地点
- 20
- 主要终点
- Postprocedure surgical challenges rate
研究概览
简要总结
The aim of this clinical trial is to evaluate the biliary drainage technical failure rate and/or the postprocedure acute pancreatitis rate between EUS-CDS vs ERCP procedures in patients with distal malignant biliary obstruction.
详细描述
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) has been extended as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). However, there are clinical trials which have compared it with ERCP as a first line treatment for MDBO in palliative patients, showing similar clinical and technical success and adverse events (AEs) rate between both techniques. Data about the benefit of this techique in potentially surgical patients is still limited.
Recent retrospective study (Janet J et al, Ann Surg Oncol 2023) and two recent meta-analysis (Barbosa E et al, GIE 2024; Gopakumar H et al, AM J Gastr 2024; both with > 500 cases) found that EUS-CDS group had significantly less technical failure rate and less postprocedure pancreatitis rate.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing those rates (technical failure, postprocedure pancreatitis) when compared to ERCP in MDBO in potentially surgical patients with resectable and borderline disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Malignant distal biliary obstruction diagnosed in patient considered RESECTABLE or POTENTIALLY RESECTABLE/BORDERLINE with biliary drainage indication: i) impaired hepatic enzymes (including hyperbilirubinemia) x3 times upper the superior normal value. ii) Radiologic singns of extrahepatic bile duct obstruction with presence of retrograde dilatation, of at least 12-mm axial diameter.
- •Consensual malignancy by a bilio-pancreatic multidisciplinar committe (histological confirmation is not mandatory)
- •Patient capable of understanding and/or singning the informed consent.
- •Patient who understands the type of study and will comply with all follow-up tests throughout its duration
排除标准
- •Pregnancy or lactation.
- •Severe coagulation disorder: INR > 1.5 non correctable with plasma administration and/or platelet count < 50.000/mm
- •Distal malignant biliary strictures in patients considered directly resectable, non-surgical, unresectable, or palliative
- •Benign or uncertain etiology of biliary strictures or strictures located proximally or in close proximity to the hilum.
- •Patients with prior biliary stents or other biliary drainages (e.g., PTCD).
- •Altered intestinal anatomy due to prior surgery that prevents or hinders papillary access (e.g., gastric bypass, Billroth II, duodenal switch, Roux-en-Y).
- •Stenosis in the antral or duodenal region that prevents access to the duodenum and reaching the papilla.
- •Situations that do not allow for upper gastrointestinal endoscopy (e.g., esophageal stricture).
- •Patients with functional diversity, who lack the capacity to understand the nature and potential consequences of the study, except when a legal representative is available.
- •Patients incapable of maintaining follow-up appointments (lack of adherence).
- •Lack of informed consent.
研究组 & 干预措施
ERCP with SEMS
Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice.
ERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment.
干预措施: Endoscopic biliary drainage (Procedure)
ERCP with SEMS
Endoscopic retrograde cholangiopancreatography (ERCP) with deployment of a self-expandable metallic stent (SEMS). Gold standard in malignant distal biliary obstruction (MDBO) in current practice.
ERCP technique: Cannulation with papillotome (advanced cannulation techniques are allowed). Sphincterotomy. Self-expandable metallic stent (SEMS) deployment.
干预措施: Self-expandable metallic stent (SEMS) (Device)
EUS-CDS with LAMS-Pigtail
Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS.
EUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct < 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS.
干预措施: Endoscopic biliary drainage (Procedure)
EUS-CDS with LAMS-Pigtail
Echoendoscopy-guided Choledochoduodenostomy (EUS-CDS) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS.
EUS-CDS technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire choledochoduodenostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. In case of bile duct < 15mm is mandatory the 'push' technique. Deployment of a pigtail coaxial to LAMS.
干预措施: Lumen-apposing metal stent (LAMS) and double-pigtail plastic stent (DPPS) (Device)
结局指标
主要结局
Postprocedure surgical challenges rate
时间窗: 1 day to 24 months
Percentage of biliary drainage technical failure and/or percentage of postprocedure acute pancreatitis.
次要结局
- Clinical success(14 days after BD)
- AE - biliary drainage(0 to 30 days after BD)
- AE - surgery(0 to 90 days after surgery)
- Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)(1 day to 6 months)
- Rate of surgery(1 to 24 months)
研究者
Joan B Gornals
PhD and Head of Interventional Endoscopy Unit
Hospital Universitari de Bellvitge