Incidence of Postoperative Pancreatic Fistula in the Resection of the Left Pancreas With a Radiofrequency Assisted Transection Device (RFAT-Pancreas)
试验速览
- 阶段
- 不适用
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS)
研究概览
简要总结
This study evaluates the impact of the Radiofrequency assisted transection on the rate of postoperative pancreatic fistula (POPF) after performing distal pancreatectomies, central pancreatectomies and pancreatic enucleation
详细描述
Among the different methods for sealing the remaining pancreas, resection and sealing devices assisted by radiofrequency energy (RF) have been used, both in experimental studies and in clinical trials, in order to try to reduce the POPF rate. One of these devices is the Coolinside®, which is approved for this indication and is currently used in selected cases, at the Hospital del Mar, among other centers.
Although there are several published studies based on similar technology, the existing publications on the use of Coolinside® in the pancreas have been made in rat and pig animal models. In particular, the most recent study published by Dorcaratto et al. compares the Coolinside device vs. the mechanical stapler in porcine model when performing distal pancreatectomies. The results suggest that the Coolinside device was more efficient in the control of the POPF than the stapler with a POPF index of 12% vs. 36%.
Therefore, this study aims to obtain more clinical evidence about the use of Coolinside in pancreatic resections within a clinical context.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with benign or malignant lesions of the pancreas
- •Subjected to distal, central pancreatectomy or enucleations of the left pancreas
- •Patients ASA (American Society of Anesthesiologists I-III
- •Open or laparoscopic approach.
排除标准
- •ASA ≥IV patients
- •Patients with limitrophic or neuroendocrine lesions
结局指标
主要结局
Postoperative pancreatic fistula according the 2016 update of the International Study Group (ISGPS)
时间窗: 1 month
"Grade A postoperative pancreatic fistula" is now redefined and called a "biochemical leak," because it has no clinical importance and is no longer referred to a true pancreatic fistula. Postoperative pancreatic fistula grades B and C are confirmed but defined more strictly. In particular, grade B requires a change in the postoperative management; drains are either left in place \>3 weeks or repositioned through endoscopic or percutaneous procedures. Grade C postoperative pancreatic fistula refers to those postoperative pancreatic fistula that require reoperation or lead to single or multiple organ failure and/or mortality attributable to the pancreatic fistula.
次要结局
- Sex(Inclusion of the patient in the study)
- Age(Inclusion of the patient in the study)
- Consistency of the pancreas(Inclusion of the patient in the study)
- Level of jaundice(At the moment of the intervention and during the first week of postoperative period)
- Type of surgical procedure(Inclusion of the patient in the study)
- Laparoscopic or open surgery(Inclusion of the patient in the study)
- Total bleeding(During the intervention)
- Size of the pancreatic duct(CT scan prior to surgery)
- Type of tumour(Diagnosis)
- Postoperative follow-up(1 year)
- Type of the postoperative complication(1 month)
- Body Mass Index (BMI)(Prior the surgery and during the PO follow-up (1 and 6 months))
- Diabetes(Before the precedure and during the PO follow-up (1 and 6 months))
研究者
Rita Quesada
Clinical Trial Monitor
Hospital del Mar