The Effect of Application of TachoSil® in Pancreatoduodenectomy

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy

Conditions
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Pancreatic Neoplasm, Pancreatic Periampullary Cancer, Pancreatic Bordeline Tumor

Intervention / Treatment
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* Drug: Fibrinogen/thrombin-coated collagen patch


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: application of TachoSil®<br>Fibrinogen/thrombin-coated collagen patch (TachoSil®) and fibrin glue are applied to the pancreas anastomosis site in pancreatoduodenectomy | Drug: Fibrinogen/thrombin-coated collagen patch<br>* Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it<br>* Other names: TachoSil®;|
| No Intervention: control<br>Only fibrin glue alone is applied to the pancreas anastomosis site in pancreaticoduodenectomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At 3 days after surgery | 
| 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. | At 5 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Through study completion, an average of 1 year | 
| 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. | 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 | 
| 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. | From date of surgery to 30 days after discharge | 
| Re-admission rate | Includes all cases of re-admission after discharge due to problems associated with pancreatoduodenectomy. Except for cases not related to pancreaticoduodenectomy. | Through study completion, an average of 1 year | 
| Period of hospitalization after surgery | The duration of the hospital stay is calculated based on the time when the actual patient is discharged. | From date of surgery until the date of discharge, whichever came first, assessed up to study completion, an average of 1 year |