Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Single-arm Phase II Trial of Intra-operative Application of HEMOPATCH to the Pancreatic Stump to Prevent Post-operative Pancreatic Fistula Following Distal Pancreatectomy
Brief Summary: Despite improvements and advances in pancreas surgery, about 30-35% of patients who have pancreas surgery develop a type of complication called a pancreatic fistula. A pancreatic fistula occurs when fluid produced by the pancreas leaks into the abdomen after pancreas surgery. Patients who develop a pancreatic fistula can have poor short-term and long-term consequences.We are studying the effect of a medical device named HEMOPATCH on the development and seriousness of pancreatic fistulas. HEMOPATCH is a thin, flexible bovine protein-based pad that may improve tissue sealing where it is applied during surgery. Some small studies called case studies of between 2 and 7 patients, and two clinical trials have shown that HEMOPATCH is effective at stopping bleeding and reducing drain output after some types of surgery. However, there have been no completed clinical trials using HEMOPATCH to prevent or reduce pancreatic fistulas in patients having pancreas surgery, so we don't know if it works in this setting. Health Canada has approved the use of HEMOPATCH as a device to stop bleeding or seal other bodily fluids for procedures in which the control of bleeding or leakage of other body fluids or air by standard surgical techniques are either ineffective or impractical.


Options:
A: 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
B: 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
C: 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..
D: Inclusion Criteria:

* Scheduled to undergo distal pancreatectomy surgery that is open or laparoscopic, with or without splenectomy
* Age ≥ 18 years
* Able and willing to comply with study procedures and follow-up examinations contained within the written consent form

Exclusion Criteria:

* Contraindication to placement of HEMOPATCH tissue sealant including: 1) Known hypersensitivity to bovine proteins; 2) Known hypersensitivity to brilliant blue \[FD\&C Blue No.1 (Blue 1)\]; 3) Presence of an active infection; and 4) Known pregnancy or lactation (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation)
* Participating in another interventional trial that may result in co-intervention or contamination (to be determined by sponsor)

Answer: D