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The Effect of Application of TachoSil® in Pancreatoduodenectomy

NCT03269955 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2017-09-01

No results posted yet for this study

Summary

Fibrinogen/thrombin-coated collagen patch (TachoSil®) is known to have the effect of strengthening tissue anastomosis and promoting suturing to prevent leakage. The purpose of this study is to compare the incidence of pancreatic fistula that is most crucial for surgical outcome and complications in pancreaticoduodenectomy with those of the control group and the TachoSil® apply group.

Patients who were planned to undergo pancreaticoduodenectomy without a history of chronic pancreatitis are enrolled in this open-label, single-center, randomized, single-blind, phase 4 clinical trial.

Conditions

  • Pancreatic Neoplasm
  • Pancreatic Periampullary Cancer
  • Pancreatic Bordeline Tumor

Interventions

DRUG

Fibrinogen/thrombin-coated collagen patch

Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Principal Investigators

  • Jaehoon Lee, Ph.D · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • South Korea

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 NCT03269955 on ClinicalTrials.gov