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Use of Hemopatch as a Sealant at the Pancreaticojejunostomy After Pancreatoduodenectomy

NCT03419676 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-02-11

No results posted yet for this study

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.

Conditions

  • Pancreatic Fistula

Interventions

DEVICE

Hemopatch

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

Sponsors & Collaborators

  • Aragon Health Science Institute

    collaborator OTHER_GOV

  • Hospital Miguel Servet

    lead OTHER

Principal Investigators

  • Mario Serradilla · Hospital Miguel Servet

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-06-30
Completion
2022-02-10

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03419676 on ClinicalTrials.gov