NCT02238847已完成不适用
Randomized Controlled Trial Comparing Covered and Uncovered Biliary Self Expanding Metal Stents (SEMS) for Pre-operative Drainage During Neoadjuvant Therapy in Patients With Pancreatic Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 18
- 主要终点
- Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
研究概览
简要总结
The purpose of this study is to demonstrate non-inferiority of Fully Covered biliary SEMS to Uncovered biliary SEMS in biliary drainage for the pre-operative management of biliary obstructive symptoms caused by pancreatic cancer in patients undergoing neoadjuvant therapy.
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
- •Age 18 or older
- •Patient indicated for biliary metal stent placement for the treatment of jaundice and/or cholestasis
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study
- •Suspicion of pancreatic adenocarcinoma
- •Likely indicated for neoadjuvant treatment
- •Distal biliary obstruction consistent with pancreatic cancer
- •Location of distal biliary obstruction such that it would allow the proximal end of a stent to be positioned at least 2 cm from the hilum
- •Endoscopic and surgical treatment to be provided at the same institution
排除标准
- •Benign biliary strictures
- •Malignancy secondary to Intraductal Papillary Mucinous Neoplasm
- •Surgically altered anatomy where ERCP is not possible
- •Previous biliary drainage using a SEMS or multiple plastic stents
- •Contraindications for endoscopic techniques
- •Patients who are currently enrolled in another investigational trial that would directly interfere with the current study
- •Pregnancy
结局指标
主要结局
Sustained Biliary Drainage, Defined as Absence of Reinterventions for the Management of Biliary Obstructive Symptoms
时间窗: From SEMS placement until CIS (for patients undergoing CIS; median 110 days to CIS) or from SEMS placement to one year after SEMS placement (for patients not undergoing CIS)
Sustained biliary drainage, defined as absence of reinterventions for the management of biliary obstructive symptoms, assessed from self-expanding metal stent (SEMS) placement until curative intent surgery (CIS) when applicable, or to one year after SEMS placement otherwise.
次要结局
- Procedure-related or Stent-related Serious Adverse Events(From stent placement procedure up to one year after stent placement procedure)
- Technical Success(During the Stent Placement Procedure)
- Ability to Complete Neoadjuvant Therapy as Intended Without Stent-related Interruptions of Neoadjuvant Therapy and Without Biliary Reintervention(From initial stent placement procedure to curative intent surgery (CIS) (median 110 days to CIS), or from initial stent placement procedure to one year after initial stent placement for participants not undergoing CIS)
- Number of Participants With Stent Migration(At the time of curative intent surgery (CIS) (median 110 days to CIS) or transition to palliation for participants not underoing CIS)
- Subjective Impression of the Surgeon That the Presence of a Self-expanding Metal Stent May Have Impacted the Surgical Procedure(At the time of curative intent surgery (CIS) (median 110 days to CIS))
- For Participants Not Undergoing Curative Intent Surgery, Sustained Biliary Drainage to One Year After Stent Placement(From stent placement to one year after stent placement for participants not undergoing curative intent surgery)
研究者
研究点 (18)
Loading locations...
相似试验
已完成
不适用
Partially Covered and Uncovered Metal Stent for Malignant Distal Biliary StrictureMalignant Distal Biliary StrictureNCT02178618Ajou University School of Medicine
已完成
不适用
Comparison of Drug Eluting Stent and Covered Metal Stent in Malignant Biliary Obstruction (MIRA III)Biliary ObstructionBiliary NeoplasmsPancreatic NeoplasmsNCT02460432Taewoong Medical Co., Ltd.106
招募中
3 期
Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus AureusCatheter BacteremiaStaphylococcus Aureus InfectionNCT05117398Assistance Publique - Hôpitaux de Paris406
已完成
3 期
Standardization of Surgery on the Pancreatic CancerPancreatic CancerNCT00679913Seoul National University Hospital244
已完成
4 期
Maribavir vs. Valganciclovir for CMV Prophylaxis in High-Risk Kidney Transplant RecipientsTransplant ComplicationCMVNCT06034925Medical University of South Carolina70