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The Effect of Application of TachoSil® in Pancreatoduodenectomy

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ClinicalTrials.gov Identifier: NCT03269955
Recruitment Status : Unknown
Verified August 2017 by Jae Hoon Lee, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : September 1, 2017
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Jae Hoon Lee, Asan Medical Center

Brief 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.


Condition or disease Intervention/treatment Phase
Pancreatic Neoplasm Pancreatic Periampullary Cancer Pancreatic Bordeline Tumor Drug: Fibrinogen/thrombin-coated collagen patch Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Experimental: application of TachoSil®
Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy
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
Other Name: TachoSil®

No Intervention: control
Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.



Primary Outcome Measures :
  1. Incidence of pancreatic fistula [ Time Frame: At 3 days after surgery ]
    The evaluation of the pancreatic fistula was based on the international study group of pancreatic fistula (ISGPF). According to the criteria, evaluation of pancreatic fistula was evaluated by measuring the amylase level of the drain tube on the third postoperative day, and the pancreatic fistula was judged to be present when the amylase level was three times higher than the normal level of the amylase in the blood.

  2. Incidence of clinically relevant pancreatic fistula [ Time Frame: At 5 days after surgery ]
    The grade uses ISGPF grading, while the grades B and C are clinically relevant pancreatic fistula. All patients underwent abdominal CT at 5 days postoperatively for grade evaluation.


Secondary Outcome Measures :
  1. Incidence of complication except for pancreatic fistula [ Time Frame: Through study completion, an average of 1 year ]
    Complications other than pancreatitis include all complications after pancreatoduodenectomy. Delayed gastric emptying and postoperative bleeding complied with the criteria of the International Study Group, and the severity of complications is classified through the Clavien-Dindo classification.

  2. Removal time of drainage [ Time Frame: From date of surgery until the date of the last drainage removal, whichever came first, assessed up to study completion, an average of 1 year ]
    The timing of removal of the drain tube is determined based on the time of removal of the last drain tube. The removal of the drain tube is assessed at the discretion of the surgeon.

  3. Death [ Time Frame: From date of surgery to 30 days after discharge ]
    The results are for patients who died during hospitalization. If a patient is discharged within 30 days of discharge, the death rate is the same as during death.

  4. Re-admission rate [ Time Frame: Through study completion, an average of 1 year ]
    Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy.

  5. Period of hospitalization after surgery [ Time Frame: From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year ]
    The duration of the hospital stay is calculated based on the time when the actual patient is discharged.



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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ECOG performance score of 0-2
  • Periampulary cancer or borderline tumor that is able to resection on preoperative examination
  • Patients without distance metastasis
  • Bone marrow function: WBC at least 3,000/mm3 or absolute neutrophil count at least 1,500/mm3, Platelet count at least 125,000/mm3
  • Liver function: AST/ALT less than 3 times upper limit of normal
  • Kidney function: Creatinine no greater than 1.5 times upper limit of normal
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Patients with distant metastases are not eligible
  • Recurred periampulary cancer
  • Pregnant and breastfeeding women
  • Patients with active or uncontrolled infection
  • Patients with uncontrolled heart disease
  • Patients with moderate or severe comorbidities who are thought to have an impact on quality of life or nutritional status (Liver cirrhosis, chronic kidney failure, heart failure, etc.)
  • Patients who underwent other major abdominal organs surgery except for scheduled pancreatoduodenectomy (gastrectomy, colonic resection, etc.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03269955


Contacts
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Contact: Jaehoon Lee, Ph.D +82-2-3010-1521 hbpsurgeon@gmail.com
Contact: Sookyung Lee +82-2-3010-6921 goggle44@naver.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Songpagu, Korea, Republic of, 05505
Contact: Jaehoon Lee, Ph.D    +82-2-3010-1521    hbpsurgeon@gmail.com   
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Jaehoon Lee, Ph.D Asan Medical Center

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae Hoon Lee, M.D, Ph.D, Asan Medical Center
ClinicalTrials.gov Identifier: NCT03269955     History of Changes
Other Study ID Numbers: 2016-0791
First Posted: September 1, 2017    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Thrombin
Fibrin Tissue Adhesive
Hemostatics
Coagulants