Spontaneous Dislocation and Adverse Events of a Prophylactic Pancreatic Stent: a Prospective, Randomised, Multicenter Study (SAFE PANCREAS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 358
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
A multicenter, prospective, controlled randomized study to investigate the optimal duration of protective pancreatic stents after endoscopic retrograde cholangiopancreatography (ERCP).
The primary endpoint is the complication rate that can be clinically attributed to the remaining pancreatic prosthesis or its removal in the study groups. Secondary endpoints are spontaneous removal of the pancreatic stent, length of hospital stay, rate of follow-up examinations per group, influencing factors, and a possible exploratory analysis.
详细描述
After study consent, randomization takes place into the standard group (removal of the protective pancreatic stent after 12 hours at the earliest and 10 days at the latest by esophagogastroduodenoscopy/ERCP) or into the intervention group (removal of the protective pancreatic stent after 4 weeks at the earliest, but no later than 3 months).
Both the baseline data and randomization are planned on a secure online platform (http://myresearchmanager.com).
Before removing the pancreatic stent, non-invasive diagnostics may be performed in accordance with hospital standards, and endoscopy may be omitted if the pancreatic stent is found to be displaced.
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
- •prophylactic pancreatic stent (5Fr 4cm length)
- •informed consent
排除标准
- •necrotising post-ercp-pancreatitis
- •pregnancy/breastfeeding
- •Billroth II
研究组 & 干预措施
Standard
Standard time of the removal
干预措施: standard group (Device)
Interventional - delayed removal
Stent removal after 1 - 3 months
干预措施: pancreatic stent removal (Device)
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: From enrollment to the end of treatment at 6 months
Side effects (number and type) which occur due to the stent insertion, retention after more than 10 days and/or after the removal of the stent
次要结局
- Spontaneous dislocation(From enrollment to the end of treatment 6 months)
- Follow-up examinations for pancreatic stent detection(From enrollment to the end of treatment at 6 months)
- ERCP procedures(During visit Nr 1 (Day 10 after enrollment))
- Days of hospital stay(From the date of hospital admission (Day 1) up to hospital discharge, assessed up to 90 days.)
- Explorative analysis of the collected data(Through study completion, an average of 1 year)
研究者
Georg Dultz
Senior Physician at Clinic of Gastroenterology, Johann Wolfgang Goethe University Hospital
Johann Wolfgang Goethe University Hospital