CTRI/2024/09/073581尚未招募2/3 期
E7179 Fully Covered Self-Expanding Metal Stents for Pancreatic Duct Strictures in Patients with Chronic Pancreatitis and Pain Reduction during Prior Single Pancreatic Plastic Stent Placement
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- PRIMARY EFFECTIVENESS ENDPOINT
研究概览
简要总结
This study is a global, prospective, single arm study. It will feature two subsequent enrollment cohorts:
-
Pilot cohort: Long lengths SEMS only, up to 12 patients at up to 3 investigational sites
-
Pivotal cohort: Short and long lengths SEMS, up to 53 patients at up to 10 investigational sites
The objective of this study is to prospectively document the performance of a fully covered self-expanding metal stent (FCSEMS) (“study stentâ€) for treatment of pancreatic duct (PD) strictures in patients with painful chronic pancreatitis (CP) and pain reduction during prior single pancreatic plastic stent (PPS) placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Age 18 or older
- •Willing and able to comply with study procedures and follow-up schedule and provide written informed consent to participate in study
- •Chronic pancreatitis-induced stricture of Cremer Type IV, namely distal dominant stricture with upstream ductal dilation prior to PPS placement
- •Minimum 5mm diameter of dilated duct immediately upstream of pancreatic duct stricture prior to PPS placement
- •Availability of narcotic dosage for at least one month prior to PPS placement
- •Prior clearance of pancreatic stones where needed o If pancreatic duct stone clearance includes ESWL, then a single PPS may be placed immediately after the ESWL procedure at the discretion of the Investigator (e.g., if there is concern about fragments of stone sludge in the side branches of the pancreatic duct).
- •NOTE: Per exclusion criterion #10, the indwell duration of a single PPS or the cumulative duration of consecutive, single PPS immediately prior to FCSEMS placement may not exceed 90 days.
- •o If new pancreatic duct stones requiring ESWL have formed by the time of intended FCSEMS placement, then the patient will not receive the FCSEMS and be excluded from the study.
- •Further treatment of the patient will be provided per standard of practice outside of the study.
- •History of documented pain relief during PPS indwell (assessed via Izbicki pain scale), defined as: o Severity of pain prior to PPS placement: VAS pain score >20 (assessed via Izbicki pain scale) o Frequency of pain prior to PPS placement: Several times a month or more frequently (assessed via Izbicki pain scale) o Pain relief during PPS indwell: Primary endpoint pain score (i.e., mean of the scores of the severity and frequency sectors of the Izbicki pain scale) after PPS placement <10, or ˃10 but reduced by at least 50% compared to score prior to PPS placement
- •Prior endoscopic pancreatic sphincterotomy (EPS), historically or to be provided at time of FCSEMS placement as applicable.
排除标准
- •Pancreatic or peri-ampullary cancer with or without pancreatic duct strictures caused by malignancy
- •Biliary strictures caused by chronic pancreatitis that are symptomatic and/or in need of therapeutic intervention
- •Perforated duct
- •Ansa pancreatica
- •Presence of pancreatic cysts suspected to be cystic tumor or requiring transmural drainage
- •Duodenal/groove pancreatitis
- •Autoimmune pancreatitis
- •Pancreatic duct stenoses not located in the head of the pancreas
- •Failed access during an attempted ERCP on a prior date at the investigational center
- •Duration of indwell of a single PPS or cumulative duration of consecutive single PPS immediately prior to FCSEMS placement exceeding 90 days
- •History of prior multiple side-by-side PPS up to one year prior to enrollment
- •Increase of average daily narcotic dose by ≥50% during single PPS indwell
- •History of prior pancreatic metal stent(s)
- •Reported recent history of acute relapsing pancreatitis in the absence of chronic pancreatitis
- •Patients for whom endoscopic techniques are contraindicated
- •Patients who are currently enrolled in another investigational study that would directly interfere with the current study, without prior written approval from the sponsor
- •Inability or refusal to comply with the follow-up schedule, including patients living at such a distance from the investigational center that attending follow-up visits would be unusually difficult or burdensome
- •Women who are, or plan to become, pregnant during the course of the study.
结局指标
主要结局
PRIMARY EFFECTIVENESS ENDPOINT
时间窗: Following the study device procedure, follow-up visits will occur at Month 1, Month 3, and Month 6.
Maintenance of pain relief 6 months after study stent removal or observation of complete distal migration (CDM)
时间窗: Following the study device procedure, follow-up visits will occur at Month 1, Month 3, and Month 6.
PRIMARY SAFETY ENDPOINT
时间窗: Following the study device procedure, follow-up visits will occur at Month 1, Month 3, and Month 6.
Rate of related serious adverse events (SAEs)
时间窗: Following the study device procedure, follow-up visits will occur at Month 1, Month 3, and Month 6.
次要结局
- Stricture resolution(Time of study stent removal or observation of complete or partial study stent migration)
- Stent functionality(Study stent placement until study stent removal or observation of complete or partial study stent migration)
- Izbicki pain scale(Assessed at each study visit)
- Average daily narcotic dose for the prior month(Assessed at each study visit)
- Study stent placement success(Study stent placement)
- Endoscopic study stent removal success(Study stent removal)
- Device deficiencies(Study stent placement through end of study)
研究者
研究点 (1)
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