Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Fistula
• Intervention / Treatment: Device: Hemopatch

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain, 50008
    • Mario Serradilla Martín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; No reinforcement.
Experimental: Hemopatch; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Miguel Servet
• Collaborators: Aragon Health Science Institute
• Investigators: Principal Investigator: Mario Serradilla, Hospital Miguel Servet

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: December 10, 2017
• First Submitted That Met QC Criteria: January 27, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Pancreatoduodenectomy; Postoperative pancreatic fistula; Hemopatch; Sealant
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: C1834-MADIT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No