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The Effect of Application of TachoSil® in Pancreatoduodenectomy

Primary Purpose

Pancreatic Neoplasm, Pancreatic Periampullary Cancer, Pancreatic Bordeline Tumor

Status
Unknown status
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fibrinogen/thrombin-coated collagen patch
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pancreatic Neoplasm

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Asan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

application of TachoSil®

control

Arm Description

Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy

Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.

Outcomes

Primary Outcome Measures

Incidence of pancreatic fistula
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.
Incidence of clinically relevant pancreatic fistula
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

Incidence of complication except for pancreatic fistula
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.
Removal time of drainage
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.
Death
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.
Re-admission rate
Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy.
Period of hospitalization after surgery
The duration of the hospital stay is calculated based on the time when the actual patient is discharged.

Full Information

First Posted
August 23, 2017
Last Updated
August 30, 2017
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03269955
Brief Title
The Effect of Application of TachoSil® in Pancreatoduodenectomy
Official Title
The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 27, 2017 (Actual)
Primary Completion Date
May 2018 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Neoplasm, Pancreatic Periampullary Cancer, Pancreatic Bordeline Tumor

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
application of TachoSil®
Arm Type
Experimental
Arm Description
Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy
Arm Title
control
Arm Type
No Intervention
Arm Description
Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy.
Intervention Type
Drug
Intervention Name(s)
Fibrinogen/thrombin-coated collagen patch
Other Intervention Name(s)
TachoSil®
Intervention Description
Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it
Primary Outcome Measure Information:
Title
Incidence of pancreatic fistula
Description
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.
Time Frame
At 3 days after surgery
Title
Incidence of clinically relevant pancreatic fistula
Description
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.
Time Frame
At 5 days after surgery
Secondary Outcome Measure Information:
Title
Incidence of complication except for pancreatic fistula
Description
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.
Time Frame
Through study completion, an average of 1 year
Title
Removal time of drainage
Description
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.
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
Title
Death
Description
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.
Time Frame
From date of surgery to 30 days after discharge
Title
Re-admission rate
Description
Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy.
Time Frame
Through study completion, an average of 1 year
Title
Period of hospitalization after surgery
Description
The duration of the hospital stay is calculated based on the time when the actual patient is discharged.
Time Frame
From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaehoon Lee, Ph.D
Phone
+82-2-3010-1521
Email
hbpsurgeon@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sookyung Lee
Phone
+82-2-3010-6921
Email
goggle44@naver.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaehoon Lee, Ph.D
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
State/Province
Songpagu
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jaehoon Lee, Ph.D
Phone
+82-2-3010-1521
Email
hbpsurgeon@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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The Effect of Application of TachoSil® in Pancreatoduodenectomy

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