The Effect of Application of TachoSil® in Pancreatoduodenectomy

Phase 4

Conditions: Pancreatic Periampullary Cancer
Pancreatic Bordeline Tumor
Pancreatic Neoplasm

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.

Recruitment & Eligibility

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.)

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of clinically relevant pancreatic fistula	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.
Incidence of pancreatic fistula	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of complication except for pancreatic fistula	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.
Removal time of drainage	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.
Death	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.
Re-admission rate	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.
Period of hospitalization after surgery	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.