Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional
Phase: Phase 3

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.
    

Intervention name(s): Hemopatch
Intervention type(s): Device
Intervention description(s): Collagen patch derived from bovine dermis, coated with NHS-PEG, applied covering the pancreaticojejunostomy after pancreatoduodenectomy once the anastomosis is completed.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All patient data are anonymous. Each patient who meets the selection criteria and has signed the informed consent will be entered into a database and identified by a number (from 1 to 64). The list of patient identification numbers will be in the hands of the principal investigator. After carrying out the surgery, the patient number is entered into an online computerized randomization tool ("Randomizer for clinical trials"), https://www.meduniwien.ac.at/randomizer. It is a tool of the University of Vienna in Austria, where it is registered in a study, which allows, once the patient number is entered, the randomization of the same, obtaining one of the two methods to compare (32 patients in each study group):
Basic treatment: duct-to-mucosa pancreaticojejunostomy WITHOUT Hemopatch reinforcement.
The same, but reinforced WITH Hemopatch.
Once the treatment to be performed is obtained, surgery will be carried out according to the treatment obtained in the randomization.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pancreatoduodenectomy; Postoperative pancreatic fistula; Sealant; Hemopatch