Multicenter Study of EUS-guided Gallbladder Drainage vs Choledochoduodenostomy as First Line in Malignant Distal Obstruction in Palliative Patients (CARPEGIEM Trial): an Open-label, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 128
- 试验地点
- 20
- 主要终点
- RELATED ADVERSE EVENTS
研究概览
简要总结
The aim of the study is to evaluate technical, clinical and safety outcomes of lumen-apposing metal stent (LAMS) with a coaxial double-pigtail plastic stent (DPS) in EUS-guided choledochoduodenostomies vs cholcystogastrostomy for the management of malignant biliary obstruction in palliative patients.
详细描述
Ecoendoscopy-guided choledochoduodenostomy (EUS-CDS) with a biliary lumen-apposing metal stent (LAMS) has been widely accepted as a second line treatment in cases of ERCP failure in malignant distal biliary obstruction (MDBO). Recent studies (DRAMBO and ELEMENT trial) compared EUS-CDS vs ERCP as a first line treatment in MDBO in palliative patients, showing similar clinical and techinal success and adverse events rate between both techniques, demonstrating that both procedures could be options for primary biliary drainage in unresectable MDBO.
Furthermore a recent clinical trial (BAMPI trial) has proven that the addition of a coaxial double pigtail (DPS) offers benefits in terms of safey and clinical success.
In the last years there has been an increasing interest for the EUS-guided gallblader drainage (EUS-GBD) in unresectable MDBO as an alternative for EUS-CDS, and recent studies and reviews have been reported with acceptable techinal and clinical success, but no clinical trial has been performed up to date.
Our hypothesis is that EUS-GBD may offer benefits in terms of safety over EUS-CDS, maintaining similar clinical and techinal success rates.
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 100 Years（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 PALIATIVE with biliary drainage indication.
- •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
- •Previous cholecistectomy or gallblader perforation.
- •Tumoral obstruction of cystic duct.
- •Multiple liver metastases affecting more than 30% of the liver parenchyma
- •Distal malignant biliary strictures in patients considered resectable or borderline.
- •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).
- •Gastric outlet obstruction.
- •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
EUS-GBD with LAMS-Pigtail
Biliary drainage using EUS-guided Cholecystostomy with lumen apposing metal stent
Echoendoscopy-guided Cholecystostomy (EUS-GBD) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS.
EUS-GBD technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire cholecystostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. 'push' technique'. Deployment of a pigtail coaxial to LAMS.
干预措施: Endoscopic biliary drainage (Procedure)
EUS-GBD with LAMS-Pigtail
Biliary drainage using EUS-guided Cholecystostomy with lumen apposing metal stent
Echoendoscopy-guided Cholecystostomy (EUS-GBD) with deployment of a lumen-apposing metal stent (LAMS) and axis-orienting double-pigtail plastic stent throug LAMS.
EUS-GBD technique: Diagnostic EUS. Classic or free-hand with preloaded guidewire cholecystostomy with LAMS. Pneumatic dilation whithin LAMS is allowed. '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)
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
RELATED ADVERSE EVENTS
时间窗: 12 months
Safety will be measured by careful and comparative evaluation of adverse effects in both groups.
Patients with Recurrent biliary obstruction
时间窗: 12 months
Recurrent biliary obstruction (RBO) has been defined as a composite endpoint of either occlusion or migration.
次要结局
- BILIARY REINTERVENTIONS (BRI)(12 months)
- HOSPITAL STAY(12 months)
- MORTALITY(12 months)
- CLINICAL SUCCESS(2 weeks)
- COST ANALYSIS(12 months)
- TECHNICAL SUCCESS(24 hours)
研究者
Joan B Gornals
PhD and Head of Interventional Endoscopy Unit
Hospital Universitari de Bellvitge