CompletedPhase 3

Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy

Spain64 participantsStarted 2018-05-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Postoperative type B and C pancreatic fistula

Timeframe: Up to 3 months

Trial details

NCT IDNCT03419676

SponsorHospital Miguel Servet

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06-30

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