Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy
- Conditions
- Pancreatic Fistula
- Interventions
- Device: Hemopatch
- Registration Number
- NCT03419676
- Lead Sponsor
- Hospital Miguel Servet
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score < 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
- Patients scheduled for pancreatoduodenectomy by open approach, depending on the diagnosis/nature of the tumor.
- ASA score < 4.
- Male and female patients ≥ 18 and ≤ 80 years of age.
- With the consent form signed.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hemopatch Hemopatch Reinforcement with Hemopatch.
- Primary Outcome Measures
Name Time Method Postoperative type B and C pancreatic fistula 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
- Secondary Outcome Measures
Name Time Method Overall complications (according to Clavien-Dindo classification) Up to 3 months Percentage of patients
Stay in intensive care unit Up to 3 months Days of duration
Total postoperative fistula (including type A, B, and C) Up to 3 months Percentage of patients
Reoperations including interventional radiology Up to 3 months Percentage of patients
Delayed gastric emptying Up to 3 months Percentage of patients
Hemorrhage Up to 3 months Percentage of patients
Deep organ space complications Up to 3 months Deep organ space complications
Hospital stay Up to 3 months Days of duration
Biliary fistula Up to 3 months Percentage of patients
Death, irrespective of cause Up to 3 months Death
Trial Locations
- Locations (1)
Mario Serradilla Martín
🇪🇸Zaragoza, Spain