Internal Biodegradable Stent Versus Non-Stent in Patients at High-Risk of Developing Fistula After Pancreatoduodenectomy (BioSteP): a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)
研究概览
简要总结
The aim of this randomized controlled study is to compare the efficacy of biodegradable internal pancreatic stenting versus no stenting in patients undergoing pancreatoduodenectomy (PD), focusing on a possible superiority association of the device in preventing clinically relevant postoperative pancreatic fistula (CR-POPF).
Patients undergoing PD will be randomized into two arms:
- arm 1: a biodegradable internal pancreatic stent will be placed at the level of the pancreatic anastomosis
- arm 2: no pancreatic stent will be placed at the level of the pancreatic anastomosis
The rate of occurrence of CR-POPF will be compared between the two arms.
详细描述
Clinically relevant postoperative pancreatic fistula (CR-POPF) represents the most common complication that can occur after pancreatoduodenectomy (PD). CR-POPF is the main cause of morbidity after PD, being associated with a risk of mortality up to 60%. The placement of external or internal pancreatic stents after PD have been investigated as possible strategies for preventing the development of CR-POPF. However, device displacement has been reported as a common cause of pancreatic stents malfunction. Recently, a novel biodegradable pancreatic stent (ARCHIMEDES™) has been introduced. The device has been specifically designed to reduce the risk of displacement, thus offering a new valuable tool to decrease the rate of CR-POPF after PD.
In this randomised, controlled, single-center trial, researchers investigate the possible efficacy of biodegradable internal pancreatic stenting of pancreatic anastomosis in patient undergoing PD versus no stenting, focusing on a possible superiority association for preventing CR-POPF.
Participants will be randomised into two arms (Biodegradable stent vs non-stent) based on their intra-operative risk of developing POPF according to the Fistula Risk Score (FRS). The rate of CR-POPF will be compared between the two arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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
- •Patients who undergo pancreatoduodenectomy (PD)
- •Informed Consent
排除标准
- •Previous distal pancreatectomy
- •Patients with intra-operative negligible, intermediate or moderate risk of POPF (fistula risk score < 7)
研究组 & 干预措施
Non Stent
No stent will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
Biodegradable Stent
An internal biodegradable pancreatic stent (ArchimedesTM) will be placed at the level of the pancreatic anastomosis in patients undergoing pancreatoduodenectomy.
干预措施: Biodegradable Stent (Device)
结局指标
主要结局
Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF)
时间窗: from three days after surgery until 3 months after surgery
The primary objective of the study is to compare the rate of CR-POPF after PD with duct-to-mucosa pancreatico-jejunostomy (PJ) using biodegradable pancreatic internal stent vs no stent.
次要结局
- Postoperative Morbidity(from the date of surgery, up to 3 months)
- Quality of Life (QoL)(from the day before surgery until 3 months after surgery)
- Stent displacement(10 days after surgery)
- Clinically Relevant Postoperative Pancreatic Fistula (CR-POPF) severity(from three days after surgery until 3 months after surgery)
- Time to Functional Recovery (TFR)(from the date of surgery until the date of functional recovery, assessed up to 3 months)
- Length of Hospital Stay (LOS)(from the date of surgery until the date of hospital discharge, assessed up to 3 months)
- Cost-effectiveness(from the date of surgery, up to 3 months)
研究者
Stefano Partelli
Professor
Ospedale San Raffaele