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临床试验/NCT01988519
NCT01988519已完成不适用

Does the Type of Drain Influence the Postoperative Pancreatic Fistula Rate After Pancreatic Resection?

University Hospital Hradec Kralove3 个研究点 分布在 1 个国家目标入组 223 人开始时间: 2013年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
223
试验地点
3
主要终点
Postoperative pancreatic fistula

研究概览

简要总结

Pancreatic resection is the only potentially curative modality of treatment for pancreatic neoplasm. The mortality associated with this procedure decreased rapidly in the past decades. However, the morbidity associated with pancreatic resection remains high. The main reason for postoperative morbidity is postoperative pancreatic fistula (POPF), which is regarded as the most ominous complication following pancreatic resection. Its reported incidence varies in the surgical literature from 10% to >30%.

Recently published studies showed that the placement of intraoperative drains, manipulation with the drains, timing of removal of the drain, and especially the type of drain, have significant effect on the postoperative complications, and especially POPF.

Controversy exists regarding the type of intraoperatively placed drain. Nowadays, the two most commonly used systems are closed suction drainage and closed gravity drainage. Open systems have been abandoned in most centers as they are obsolete.

Our hypothesis is that the closed suction drain will have better results as it is more effective than the gravity drainage. However, some surgeons claim that the suction system can actively suck the pancreatic juice through the anastomosis or suture and thus promote the development of POPF.

The aim of this study is to compare closed suction drains and closed gravity drains after pancreatic resection in a randomized controlled study.

The primary end-point is the postoperative pancreatic fistula rate. The secondary end-point is the postoperative morbidity.

详细描述

Pancreatic resection is the only potentially curative modality of treatment for pancreatic neoplasm. The mortality associated with this procedure decreased rapidly in the past decades. However, the morbidity associated with pancreatic resection remains high. The main reason for postoperative morbidity is postoperative pancreatic fistula, which is regarded as the most ominous complication following pancreatic resection. Its reported incidence varies in the surgical literature from 10% to >30%.

Recently published studies showed that the placement of intraoperative drains, manipulation with the drains, timing of removal of the drain, and especially the type of drain, have significant effect on the postoperative complications, and especially POPF.

Even though several trials showed that the routine use of intraoperatively placed drains in elective pancreatectomy does not reduce postoperative morbidity, most of the high-volume pancreatic surgery centers still place the drains routinely. The theoretical advantage of drainage is to identify an early bile or pancreatic leak, or postoperative hemorrhage; and therefore allow for early treatment of the complication; or in some cases, the drain would control the leak without necessity of reintervention.

Two large studies compared early versus late removal of the intraoperatively placed drains. The first published by Kawai et al. was a cohort study, including 104 patients. The second one published by Bassi et al. was prospective randomized trial including 114 patients. Both studies clearly showed that the group of patients with early drain removal has superior results, lower rate of POPF and lower morbidity.

Controversy exists regarding the type of intraoperatively placed drain. The surgeons in the USA usually use the closed suction drainage system. On the other hand, European and Asian surgeons usually prefer open Penrose system, closed gravity drainage, or a combination of both. The closed suction drainage system uses slight under pressure to drain the fluid from the abdominal cavity. It is more effective than other systems, and thus advantageous. However, some surgeons claim that the suction system can actively suck the pancreatic juice through the anastomosis or suture and thus promote the development of POPF.

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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • pancreaticoduodenectomy
  • distal pancreatectomy

排除标准

  • central pancreatectomy
  • total pancreatectomy
  • enucleation
  • laparoscopic procedure
  • resection and reconstruction of portal vein

结局指标

主要结局

Postoperative pancreatic fistula

时间窗: 30 days postoperatively

Postoperative pancreatic fistula defined according to the ISGPF (International Study Group for Pancreatic Fistula)

次要结局

  • Postoperative morbidity(30 days postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Filip Cecka

MUDr. Filip Čečka, Ph.D.

University Hospital Hradec Kralove

研究点 (3)

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