Reduced Postoperative Pancreatic Fistula Rate Following Pancreaticoduodenectomy; Multicentric Randomized Controlled Trial on Pancreaticogastrostomy vs. Pancreaticojejunostomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Baki Topal
- 入组人数
- 336
- 试验地点
- 2
- 主要终点
- Reduction of clinical postoperative pancreatic fistula (POPF) rate
研究概览
简要总结
The incidence of complications after pancreaticoduodenectomy (PD) is around 50 %. The postoperative course after PD is strongly dependent of the occurrence of pancreatic fistula (POPF), which determines postoperative mortality, length of hospital stay and costs. The incidence of POPF after PD is dependent of its definition, and is reported in up to 20% of patients.
There is disagreement on whether to perform a pancreaticojejunostomy (PJ) or a pancreaticogastrostomy (PG) after PD. The aim of the current randomized controlled trial is to study whether PG significantly reduces the rate of POPF following PD for pancreatic or peri-ampullary tumours. Secondary endpoints are the reduction of overall postoperative complication rate and their severity.
详细描述
Therapeutic intervention
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Surgeons who have performed a minimum of five (5) PG and PJ procedures can include patients in this randomized trial.
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Any dissection device or technique is allowed.
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Pancreatic anastomosis (PG or PJ)
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1-layer or 2-layer anastomosis is allowed but has to be registered
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mono-filament and/or poly-filament suture material is allowed but has to be registered
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no pancreatic stent will be placed
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Drainage: one (1) or more closed drain(s) with or without suction is allowed in the vicinity of the pancreatic anastomosis
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Enteral tube feeding (tube positioned in the jejunum at the time of surgery, and distal to the pancreatic anastomosis) as well as total parenteral nutrition (TPN) is allowed
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Gastrostomy tube (percutaneous) is allowed
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Somatostatin: start intra-operatively and administered for seven (7) days after surgery at a dose of 6 mg/d
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Prophylactic use of antibiotics during 24h post-operatively
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Prophylactic use of Ranitidine as well as any PPI (proton pump inhibitor) is allowed to prevent peptic ulcer
Clinical evaluation and assessment criteria
- The number and type of POPF will be recorded according to the ISGPF guidelines and based on findings on day 3 (three) after surgery
- The number and type of postoperative complications will be recorded. The therapy-oriented severity grading system (TOSGS) of complications will be used and complications will be allocated to surgical (SSC) and non-surgical site (NSSC) complications
- The adequacy of the surgical resection margins (pR0) and the magnitude of the tumour-free resection margin (millimetres) will be monitored
- Postoperative length of hospital stay (LOS) will be registered
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients, male or female, who undergo PD for a pancreatic or peri-ampullary tumor
- •Age between 18 to 85 years
- •Patients with and without pre-operative biliary drainage (for obstructive jaundice)
- •Concomitant surgical procedures such as simultaneous colonic resection etc.
- •Reconstruction of the portal vein or superior mesenteric vein
排除标准
- •Age < 18years
- •Pregnancy
- •Pre-operative radiotherapy
- •PD for IPMT
- •PD for chronic pancreatitis
- •PD for pancreatic trauma
- •PD for post-ERCP complications
- •Any arterial reconstruction at the time of surgery
结局指标
主要结局
Reduction of clinical postoperative pancreatic fistula (POPF) rate
时间窗: 3 years
次要结局
- Reduction of overall postoperative pancreatic fistula rate(3 years)
- Reduction of the severity of postoperative complications(3 years)
研究者
Baki Topal
MD, PhD
University Hospital, Gasthuisberg