Total Pancreatectomy With Islet Autotransplantation as a Superior Alternative to Pancreatoduodenectomy in Patients at Very High-risk of Complications of the Pancreatic Anastomosis: a Single-center Prospective Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- incidence of complications after pancreatic surgery
研究概览
简要总结
The goal of the proposal is to demonstrate that, in patients with disease of the pancreatic head with very high-risk of complications of pancreatojejunal reconstruction (soft pancreas and pancreatic duct diameter <3 mm), total pancreatectomy with islet autotransplantation (IAT) is associated with a lower morbidity (in terms of surgical or medical complications) and mortality compared with pancreaticoduodenectomy and pancreatojejunal anastomosis.
详细描述
Complications of the pancreatic anastomosis still represents a significant risk for death after the resection of the pancreatic head. In an effort to decrease morbidity and mortality, the referral of patients who need a pancreaticoduodenectomy to institutions (and surgeons) performing a high volume of this surgical procedure has been championed. Nonetheless, the role of prophylactic medications and the best surgical technique(s) for the removal of the pancreatic head are still debated. However, very few prospective randomized clinical trials have been conducted to compare different surgical techniques.
Our study will address for the first time the role for preemptive total pancreatectomy and IAT in selected patients undergoing pancreaticoduodenectomy that are considered high risk for pancreaticojejunostomy disruption (eg, small pancreatic duct, soft pancreas). The information expected is the identification of total pancreatectomy and the IAT as the standard treatment in a subgroup of patient with pathologies of the pancreatic head at high risk for leakage of pancreatic anastomosis. Ultimately this project will lead to reserve more innovative cell therapy for patients with the highest risk of anastomosis failure reducing pancreatojejunal reconstruction related morbidity and mortality
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
- •Patients >18 years of age
- •Ability to provide written informed consent
- •Mentally stable and able to comply with the procedures of the study protocol
- •Fasting glycaemia <126 mg/dl without glucose-lowering medications.
排除标准
- •Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
- •Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal lesion is demonstrated by endoscopic US
- •Presence of multifocal or residual disease at the pancreatic margin.
结局指标
主要结局
incidence of complications after pancreatic surgery
时间窗: 90 days from discharge
Complications will be defined and graded according to the Novel Grading System classification ( DeOliveira et al 2006). A special emphasis is given to life-threatening and permanently disabling complications.
次要结局
- Incidence of endocrine and exocrine pancreatic insufficiency(12 months after surgery.)
- Incidence of each individual postoperative complication(90 days from discharge)
研究者
Piemonti Lorenzo
Director Islet Transplantation Program
Ospedale San Raffaele