PANasta Trial Cattell-Warren Versus Blumgart Techniques of Pancreatico-jejunostomy Following Pancreato-duodenectomy - a Double Blinded Multi Centred Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 1
- 主要终点
- Presence or absence of post-operative pancreatic fistula
研究概览
简要总结
The purpose of this study is to compare two different techniques of performing a pancreatic anastomosis; Cattell-Warren versus Blumgart to determine if a Blumgart anastomosis reduces pancreatic remnant leak, post-operative complications and overall length of hospital stay.
详细描述
This is a randomised controlled, phase III, double blinded, multicentre clinical trial comparing Cattell-Warren (CWA) versus. Blumgart (BA) methods of pancreaticojejunostomy following pancreaticduodenectomy for supected malignancy of the pancreatic head.
The primary objective of the trial is to establish if the Blumgart anastomosis reduces pancreatic remnant leak and in turn complications, hospital stay, cost and promote enhanced recorvery programs.
506 patients (253 patients per treatment arm) will be recruited from approximately 7 centres throughout the United Kingdom.
Patients recommended for resection who provide written informed consent will be randomised to one of the following treatment arms on the day of surgery by the surgeon:
Arm A: Blumgart method of panreaticojejunostomy. Arm B: CattellWarren method pf pancreaticojejunostomy.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
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 undergoing an elective pancreato-duodenectomy for presumed malignancy.
- •Ability of the subject to understand the nature and consequences of the trial.
- •Ability to rovide writen informed consent.
- •Age 18 or greater.
排除标准
- •Patients undergoing extended pancreato-duodenectomy
- •Left, central or total pancreatectomy.
- •Arterial resection or multi-visceral resection
- •Previous pancreatic surgery
- •Surgery for known chronic pancreatitis.
- •Recruited to any other pancreatic resection trial.
- •Pregnant women.
- •Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from time of consent up to the day of surgery.
研究组 & 干预措施
Blumgart Anastomosis
Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy.
Octreotide will be administered.
干预措施: Blumgart Anastomosis (Procedure)
Blumgart Anastomosis
Re-construction of the pancreatic remnant following pancreatico-duodenectomy using a "Blumgart" method of pancreatico-jejunostomy.
Octreotide will be administered.
干预措施: Octreotide (Drug)
Cattell-Warren Anastomosis
Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy.
Octreotide will be administered.
干预措施: Cattell-Warren Anastomosis (Procedure)
Cattell-Warren Anastomosis
Re-construction of the pancreatic remnant following pancreato-duodenectomy using a "Cattell-Warren" method of pancreatico-jejunostomy.
Octreotide will be administered.
干预措施: Octreotide (Drug)
结局指标
主要结局
Presence or absence of post-operative pancreatic fistula
时间窗: Assessed up to 3 months after surgery.
Post-operative pancreatic fistula are defined as any abnormal connection between the pancreatic duct epithelium and another epithelised surface, which contains pancreatic derived, enzyme rich fluid. This will be assessed up to 3 months following surgery on inpatient days 3-7, day of discharge (expected to be 1 - 5 weeks after surgery) and 3 month follow up.
次要结局
- Operation time(Day of surgery)
- Mortality Rate(Death due to any cause during the study will be recorded)
- Rate of delayed gastric emptying(Post operative day 3, 5, 7, and the day of discharge, which is expected to be between 1 - 5 weeks after surgery.)
- Rate of wound infections(Post operative day 3, 5, 7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3, 6 and 12 month follow up)
- Rate of pulmonary infection(The day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow up.)
- Entry into programs of adjuvent therapy(3, 6 and 12 month follow up)
- Rate of post-operative fluid collections(post operative days 3-7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery and 3 month follow-up)
- Rate of intra and post-operative bleeding(day of surgery, post operaive day 3, 5, 7 and the day of discharge, which is expected to be between 1 - 5 weeks after surgery)
- Rate of re-operation(Up to 12 months after surgery)
- Rate of venous thrombo-embolism(Post operative day 3, 5, 7, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow up)
- Length of hospital stay(The day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up)
- Quality of Life measured by the QLQ-C30 questionnaire(Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up)
- Health economic evaluation measured by the EQ-5D questionnaire(Enrolment, the day of discharge, which is expected to be between 1 - 5 weeks after surgery, 3, 6 and 12 month follow-up)