Pancreatic Fistula Clinical Trial
Official title:
Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy to Prevent Postoperative Pancreatic Fistula
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01696903 -
Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy
|
N/A | |
Completed |
NCT01301222 -
Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas
|
Phase 4 | |
Recruiting |
NCT05155878 -
Prognostic Factors in Periampullary Tumors and Cysts
|
||
Terminated |
NCT03757455 -
ERAS Protocol in Pancreaticoduodenectomy and Total Pancreatectomy
|
N/A | |
Recruiting |
NCT05212350 -
Total pancrEaTectomy vs High-Risk Pancreatic anastomosiS
|
N/A | |
Completed |
NCT04609137 -
Early Drain Removal Versus Standard Drain Management After Distal Pancreatectomy (Early-Dist)
|
N/A | |
Recruiting |
NCT04798560 -
Identifing Risk Factors for Pancreaticojejunostomy Leakage Following Pancreaticoduodenectomy
|
||
Completed |
NCT03627559 -
Early Detection of Anastomotic Leakage by Microdialysis Catheters
|
||
Completed |
NCT01550406 -
Use of Polyethylene Glycolic Acid or Tachocomb to Prevent Pancreatic Fistula Following Distal Pancreatectomy
|
Phase 4 | |
Recruiting |
NCT04783831 -
Biodegradable Pancreatic Stents for the Prevention of Postoperative Pancreatic Fistula After Cephalic Pancreaticoduodenectomy
|
||
Not yet recruiting |
NCT05387538 -
One-layer Versus Two-layer Duct-to-mucosa Pancreaticojejunostomy After Pancreaticoduodenectomy .
|
N/A | |
Active, not recruiting |
NCT02775227 -
HYPAR Trial - Hydrocortisone vs. Pasireotide in Reducing Pancreatic Surgery Complications
|
Phase 4 | |
Completed |
NCT02790333 -
Different Stapler Cartridge For Pancreatic Stump Texture To Prevent Pancreatic Fistula
|
N/A | |
Not yet recruiting |
NCT05657366 -
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
|
N/A | |
Recruiting |
NCT05297136 -
Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy
|
N/A | |
Completed |
NCT00931554 -
Randomized Trial of Early Versus Standard Drainage Removal After Pancreatic Resections
|
N/A | |
Completed |
NCT00679952 -
Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy
|
Phase 3 | |
Recruiting |
NCT04380506 -
Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management
|
N/A | |
Recruiting |
NCT06283160 -
Metabolomic and Immune Profiling in the Development of Pancreatic Fistulas After Cephalic Duodenopancreatectomy
|
||
Completed |
NCT02784990 -
Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions
|