Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of Application of Fibrinogen/Thrombin-coated Collagen Patch (TachoSil®) in Pancreaticojejunostomy for Prevention of Pancreatic Fistula After Pancreatoduodenectomy
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.


Options:
A: 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.)
B: Inclusion Criteria:

* Patients with an alternative-Fistula Risk Score \>15%.
* Patients with insulin-dependent diabetes.
* Cirrhotic patients or with histologically proven chronic liver disease.
* Age\> 75 years (relative criterion, ie insufficient by itself to justify the procedure and therefore to be associated with one of the other cited criteria).
* Patients with intraoperative demonstration on histological examination of lymph node metastasis;
* Patients with R1 interventions.
* Presence of minimal extra-pancreatic tumor disease not detected pre-operatively (nodule of carcinosis, single liver metastasis) and removed with the primary tumor within the same intervention;
* Patients undergoing preoperative radiotherapy / chemotherapy for tumors reconverted to surgical operability.

Exclusion Criteria:

* All other patients who undergo PD in which the eligibility conditions for the study group are not present, are enrolled in the Control Arm..
C: Inclusion Criteria:

* Expected survival time more than 12 months
* Patients with at least one of the following pathologic diseases scheduled for elective resection

  * Resectable malignancies of the pancreatic body/ tail
  * Resectable pre-malignant lesions of the pancreatic body/ tail
  * Resectable benign lesion of the pancreatic body/ tail

Exclusion Criteria:

* Current immunosuppressive therapy
* Pancreatic atrophy or calcification due to severe pancreatitis
* Chemotherapy or radiotherapy before operation
* Severe psychiatric or neurologic diseases
* Drug- and/or alcohol-abuse according to local standards
* Participation in another intervention trial with interference of a primary or secondary endpoint of this study
* Inability to follow the instructions given by the investigator
* Lack of compliance
D: Inclusion Criteria:

1. completion of a successful distal pancreatectomy with/without splenectomy
2. patient must have a pancreatic remnant in place
3. there must be a viable falciform ligament for creation of the autologous patch

Exclusion Criteria:

1. patients undergoing total pancreatectomy
2. patients undergoing distal pancreatectomy who have previously completed a right sided resection of the pancreatic head, uncinate and neck
3. failure to sign informed consent
4. pregnant patients
5. patients in whom previous surgery has eliminated the falciform ligament, i.e. previous liver resection

Answer: A