Clinical trial NCT03419676: Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy
Official title: Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy to Prevent Postoperative Pancreatic Fistula
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Fistula
Keywords: Pancreatoduodenectomy
Postoperative pancreatic fistula
Sealant
Hemopatch
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
Collaborators: name: Aragon Health Science Institute
First posted: 2018-02-05
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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):

1. Basic treatment: duct-to-mucosa pancreaticojejunostomy WITHOUT Hemopatch reinforcement.
2. 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.
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative type B and C pancreatic fistula
timeFrame: Up to 3 months
Secondary outcomes:
measure: Hospital stay
timeFrame: Up to 3 months
measure: Stay in intensive care unit
timeFrame: Up to 3 months
measure: Total postoperative fistula (including type A, B, and C)
timeFrame: Up to 3 months
measure: Reoperations including interventional radiology
timeFrame: Up to 3 months
measure: Delayed gastric emptying
timeFrame: Up to 3 months
measure: Biliary fistula
timeFrame: Up to 3 months
measure: Hemorrhage
timeFrame: Up to 3 months
measure: Deep organ space complications
timeFrame: Up to 3 months
measure: Death, irrespective of cause
timeFrame: Up to 3 months
measure: Overall complications (according to Clavien-Dindo classification)
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Mario Serradilla Martín
Study officials:
affiliation: Hospital Miguel Servet
name: Mario Serradilla
role: PRINCIPAL_INVESTIGATOR
References: