Efficacy and Safety of Exocrine Pancreatectomy With Neoprene®-Based Glue After High-risk Pancreatoduodenectomy (PD) in Patients With Pancreatic, Papilla, Duodenal, and Distal Choledochus Neoplasm
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Rate of postoperative complications of grade > II according to Dindo-Clavien classification
研究概览
简要总结
The study evaluates the safety and efficacy of Neoprene-based glue in the management of pancreatic stump after pancreatoduodenectomy (PD) in patients at high risk for pancreatic fistula and early neoplastic recurrence, compared with a population of patients at conventional risk.
详细描述
Although improved in many aspects, the PD intervention is still burdened by a significant morbidity, related above all to the delicate phase following the removal of the tumor which involves the reconstruction of the gastro-enteric, biliary and especially pancreatic pathway. Among the many variants of the reconstructive phase, that of pancreato-jejunal anastomosis is the one burdened by the highest complication rate (quantified around 40%, with a percentage of pancreatic fistula between 5% and 35%).
In cases at risk of pancreatic fistula it is possible not to perform a conventional pancreato-jejunal anastomosis, but to decide to inject into the pancreatic stump the solidifying glues with the aim of inducing a chemical pancreatectomy of the exocrine component of the pancreas.
Neoprene® (Polychloroprene) has the property of polymerizing and solidifying in an environment with a pH lower than its own (pH <12).
After a systematic review of the sporadic experiences of chemical pancreatectomy published until today, due to the increased complexity of the surgical cases of patients undergoing PD, the investigators have undertaken a formal, single-center prospective study, aimed at clarifying the safety and efficacy data of a Neoprene®-based glue in patients selected through objective criteria (such as the high risk of pancreatic fistula and early tumor recovery after pancreatoduodenectomy).
In this study is expected the prospective collection of a cohort of patients with tumor of the head of the pancreas, papilla, duodenum and distal choledochus to undergo pancreatoduodenectomy (PD) at high risk of pancreatic fistula and / or local recurrence ("Study Arm").
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an alternative-Fistula Risk Score >15%.
- •Patients with insulin-dependent diabetes.
- •Cirrhotic patients or with histologically proven chronic liver disease.
- •Age> 75 years (relative criterion, ie insufficient by itself to justify the procedure and therefore to be associated with one of the other cited criteria).
- •Patients with intraoperative demonstration on histological examination of lymph node metastasis;
- •Patients with R1 interventions.
- •Presence of minimal extra-pancreatic tumor disease not detected pre-operatively (nodule of carcinosis, single liver metastasis) and removed with the primary tumor within the same intervention;
- •Patients undergoing preoperative radiotherapy / chemotherapy for tumors reconverted to surgical operability.
排除标准
- •All other patients who undergo PD in which the eligibility conditions for the study group are not present, are enrolled in the Control Arm..
结局指标
主要结局
Rate of postoperative complications of grade > II according to Dindo-Clavien classification
时间窗: 90 days
Comparison of 90-days clinically relevant postoperative morbidity rate of grade \> II according to Dindo-Clavien classification between the two arms.
Rate of overall postoperative complications
时间窗: 90 days
Comparison of 90-days overall postoperative morbidity rate of any grade according to Dindo-Clavien classification between the two arms.
Rate of postoperative mortality
时间窗: 90 days
Comparison of 90-days postoperative mortality rate between the two arms
次要结局
- Variation of Body Mass Index after pancreatoduodenectomy(12 months)
- Number of participants with onset of post-surgical diabetes(12 months)
- Percentual variation of weight after pancreatoduodenectomy(12 months)
研究者
Vincenzo Mazzaferro
Professor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano