Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy

Pancreatic Fistula Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03419676
• Other study ID #: C1834-MADIT
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2018
• Est. completion date: February 10, 2022

Study information

• Verified date: February 2022
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 10, 2022
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula

Intervention

Device:
• Hemopatch
Collagen patch derived from bovine dermis, coated with NHS-PEG, applied covering the pancreaticojejunostomy after pancreatoduodenectomy once the anastomosis is completed.

Locations

Country	Name	City	State
Spain	Mario Serradilla Martín	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Miguel Servet	Aragon Health Science Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 3 months
Secondary	Hospital stay	Days of duration	Up to 3 months
Secondary	Stay in intensive care unit	Days of duration	Up to 3 months
Secondary	Total postoperative fistula (including type A, B, and C)	Percentage of patients	Up to 3 months
Secondary	Reoperations including interventional radiology	Percentage of patients	Up to 3 months
Secondary	Delayed gastric emptying	Percentage of patients	Up to 3 months
Secondary	Biliary fistula	Percentage of patients	Up to 3 months
Secondary	Hemorrhage	Percentage of patients	Up to 3 months
Secondary	Deep organ space complications	Deep organ space complications	Up to 3 months
Secondary	Death, irrespective of cause	Death	Up to 3 months
Secondary	Overall complications (according to Clavien-Dindo classification)	Percentage of patients	Up to 3 months