Endoscopic Ultrasound-Guided Biliary Drainage With Lumen-Apposing Stent vs Classical ERCP for First-line Therapy of Malignant Distal Biliary Obstruction in Borderline Disease: An Open-label, Multicenter Randomized Trial (CARPEDIEM-2 Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Delay in days between endoscopic biliary drainage and chemotherapy treatment start
研究概览
简要总结
The aim of this clinical trial is to evaluate temporal delay (days) between biliary drainage (EUS-CDS vs ERCP as first line therapy) and chemotherapy start in patients with borderline 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 borderline patients is still limited.
A recent retrospective study (Janet J et al, Ann Surg Oncol 2023) which included borderline patients, found that EUS-CDS group had significantly less delay (days) between biliary drainage and neoadjuvant chemotherapy start than the ERCP group with fewer endoscopy and surgery AEs.
Thus, our hypothesis is that EUS-CDS has benefits in terms of decreasing delay between biliary drainage and neoadjuvant chemotherapy start when compared to ERCP in MDBO in borderline patients.
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
- 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
- •Malignant distal biliary obstruction diagnosed in patient considered 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.
结局指标
主要结局
Delay in days between endoscopic biliary drainage and chemotherapy treatment start
时间窗: 1 day to 12 months
Number of days between intervention (T1-biliary drainage) and chemotherapy treatment start.
次要结局
- AE - biliary drainage(0 to 30 days after BD)
- Technical success(day 0)
- Clinical success(14 days after BD)
- AE - surgery(0 to 90 days after surgery)
- Delay in days between endoscopic biliary drainage and cephalic duodenopancreatectomy (CDP)(6 to 12 months)
研究者
Joan B Gornals
PhD and Head of Interventional Endoscopy Unit
Hospital Universitari de Bellvitge