跳至主要内容
临床试验/NCT03419676
NCT03419676已完成3 期

Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy to Prevent Postoperative Pancreatic Fistula

Hospital Miguel Servet2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
64
试验地点
2
主要终点
Postoperative type B and C pancreatic fistula

研究概览

简要总结

The objective of this study is to determine the effect of the sealant patch Hemopatch, compared to current practice without any sealant, on the decrease of the postoperative pancreatic fistula on patients undergoing pancreatoduodenectomy for benign or malignant tumors or other benign process.

详细描述

Pancreaticoduodenectomy (PD) is the most common surgical procedure to treat pancreatic tumors in the head of the pancreas and periampullary region, as well as benign processes such as chronic pancreatitis. Recent advances in surgical techniques and perioperative treatments have reduced perioperative mortality below 10% in high volume centers. However, PD is associated with considerable morbidity (40-58.5%) like postoperative pancreatic fistula, delayed gastric emptying, biliary fistula, postoperative hemorrhage, and pulmonary complications.

Several surgical techniques and perioperative care have been described to prevent or reduce the incidence of pancreatic fistula after PD, including reconstruction of the digestive tract with pancreaticogastrostomy, duc-to-mucosa reconstruction or pancreaticojejunostomy by intussusception, use of somatostatin and prophylactic analogues, the use of stents in the main pancreatic duct, and use of different sealants.

Although perioperative morbidity and mortality associated with PD have improved significantly over the years, even in high-volume centers, the incidence of postoperative fistula remains at 9.9-28.5%. Therefore, the ideal pancreatic reconstruction technique that prevents fistula is not yet available.

The use of sealants has been one of the approaches taken to try to reduce the rate of fistulas. Some uncontrolled or non-randomized studies have shown that the use of fibrin glue-based adhesives in combinations with felting patches can lead to a B / C grade fistula rate of 0-10%. Only 2 randomized clinical trials have been performed with fibrin glue, with opposite results in terms of significant reduction of pancreatic fistula.

Hemopatch is a patch consisting of a soft, thin and flexible pad of collagen derived from the bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate). It is intended to be a surgical sealant for procedures in which control of leakage by conventional surgical techniques is ineffective or impractical, making it a plausible option to use during PD in order to decrease postoperative pancreatic fistula.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
  • ASA score <
  • Male and female patients ≥ 18 and ≤ 80 years of age.
  • With the consent form signed.

排除标准

  • Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
  • ASA score <
  • Male and female patients ≥ 18 and ≤ 80 years of age.
  • With the consent form signed.

结局指标

主要结局

Postoperative type B and C pancreatic fistula

时间窗: Up to 3 months

Postoperative type B and C pancreatic fistula rate defined according to the International Study Group of Pancreatic Fistula criteria, measured by amylases and/or lipases levels in the perianastomotic drainage

次要结局

  • Hospital stay(Up to 3 months)
  • Stay in intensive care unit(Up to 3 months)
  • Total postoperative fistula (including type A, B, and C)(Up to 3 months)
  • Reoperations including interventional radiology(Up to 3 months)
  • Delayed gastric emptying(Up to 3 months)
  • Biliary fistula(Up to 3 months)
  • Overall complications (according to Clavien-Dindo classification)(Up to 3 months)
  • Hemorrhage(Up to 3 months)
  • Deep organ space complications(Up to 3 months)
  • Death, irrespective of cause(Up to 3 months)

研究者

发起方
Hospital Miguel Servet
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mario Serradilla, MD, FACS

Professor, Attending Surgeon

Hospital Miguel Servet

研究点 (2)

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