A Phase 3 interventional study of Hemopatch in Pancreatic Fistula, sponsored by Hospital Miguel Servet. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-02-11.
Sponsored by Hospital Miguel Servet · Phase 3, Interventional, and Prevention
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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.
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.
122 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.
This study's enrollment of 64 is below the median of 110 across 77 interventional studies indexed under Pancreatic Fistula.
Browse Pancreatic Fistula studies →Hospital Miguel Servet is the lead sponsor of 25 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No reinforcement.
Reinforcement with Hemopatch.
Device: Hemopatch
Collagen patch derived from bovine dermis, coated with NHS-PEG, applied covering the pancreaticojejunostomy after pancreatoduodenectomy once the anastomosis is completed.
Postoperative type B and C pancreatic fistula
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
Time frame: Up to 3 months
Hospital stay
Days of duration
Time frame: Up to 3 months
Stay in intensive care unit
Days of duration
Time frame: Up to 3 months
Total postoperative fistula (including type A, B, and C)
Percentage of patients
Time frame: Up to 3 months
Reoperations including interventional radiology
Percentage of patients
Time frame: Up to 3 months
Delayed gastric emptying
Percentage of patients
Time frame: Up to 3 months
Biliary fistula
Percentage of patients
Time frame: Up to 3 months
Hemorrhage
Percentage of patients
Time frame: Up to 3 months
Deep organ space complications
Deep organ space complications
Time frame: Up to 3 months
Death, irrespective of cause
Death
Time frame: Up to 3 months
Overall complications (according to Clavien-Dindo classification)
Percentage of patients
Time frame: Up to 3 months
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Jun 2020, 25 months.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Hospital Miguel Servet