Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized Controlled Trial on the Effect of Intermittent Pedicle Clamping Using 15 or 30 Minutes Ischemic Intervals During Liver Surgery
Brief Summary: In order to prevent excessive blood loss during liver surgery, an intermittent Pringle manoeuvre (IPM) can be applied. This implies a temporary clamping of the portal vein and hepatic artery in the hepatoduodenal ligament in order to occlude hepatic inflow. The optimal duration of the IPM is unknown. This randomized controlled trial aimed to analyse differences in hepatocellular damage after 15 minutes or 30 minutes IPM during liver surgery for primary or secondary liver tumours.


Options:
A: DISEASE CHARACTERISTICS:

* Diagnosis of potentially resectable colorectal liver metastases that meets one of the following criteria:

  * Metachronous metastases after complete resection of primary tumor without gross or microscopic evidence of residual disease
  * Synchronous metastases after complete resection of primary tumor more than 1 month before study
  * Synchronous metastases with sufficient evidence (i.e., CAT scan or diagnostic laparoscopy) that both the primary tumor and liver metastases can be completely resected during the same procedure and resection of primary may be delayed 3-4 months

PATIENT CHARACTERISTICS:

Age:

* 18 to 80

Performance status:

* WHO 0-2
* Karnofsky 60-100%

Life expectancy:

* Not specified

Hematopoietic:

* Absolute neutrophil count greater than 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* No hepatic insufficiency

Renal:

* Creatinine less than 2 times upper limit of normal

Cardiovascular:

* No uncontrolled congestive heart failure or angina pectoris
* No hypertension or arrhythmia

Other:

* No other malignancy within the past 10 years except adequately treated carcinoma in situ of the cervix or nonmelanoma skin cancer
* No peripheral neuropathy greater than grade 1
* No prior significant neurologic or psychiatric disorders
* No active infection
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent biologic therapy

Chemotherapy:

* No prior chemotherapy for advanced disease
* Prior adjuvant chemotherapy for primary cancer allowed unless included oxaliplatin
* No other concurrent chemotherapy

Endocrine therapy:

* No concurrent anticancer endocrine therapy

Radiotherapy:

* No concurrent radiotherapy

Surgery:

* See Disease Characteristics

Other:

* At least 30 days since prior investigational drugs
* No concurrent investigational drugs
B: Inclusion Criteria:

* Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access

Exclusion Criteria:

* Subject has undergone a therapeutic surgical procedure within 30 days prior to surgery
* Subject has history of heparin-induced thrombocytopenia
* Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment
* Subject has received blood products within 24 hours prior to surgery
C: Inclusion:

* Age: \> 18 years
* Gender: male / female
* Patients with an indication for liver resection (segmental or non-segmental)
* Willing and able to complete the clinical trial procedures, as described in the protocol
* Signed written informed consent to participate in this clinical trial

Exclusion:

* Presence or sequelae of coagulation disorder, liver cirrhosis, Klatskin tumor
* Concurrent participation in another clinical trial with a medical device or medicinal product or with interfering endpoints
* Concurrent or previous therapy with systemic pharmacologic agents promoting blood clotting including but not limited to tranexamix acid, activated factor VII, and aprotinine
* Known allergy or hypersensitivity to a component of the investigational treatments Sangustop® or TachoSil®, to riboflavin or to proteins of bovine origin
* Pregnancy or breast feeding
* Inability to understand the nature and the extent of the trial and the procedures required
* Missing signed written informed consent to participate in the study

Exclusion criteria to be checked during surgery (liver resection):

* Resection area estimated by operating surgeon \< 16cm2
* Infected wound area
* Persistant major bleeding after primary haemostasis
* No bleeding after resection
D: Inclusion Criteria:

* patients \> 18 years of age and \< 100 years of age
* primary or secondary liver tumours requiring liver surgery

Exclusion Criteria:

* pre-existent liver disease (e.g. inflammatory liver disease, cirrhosis, inborn errors of metabolism)
* cholangiocarcinoma requiring biliary tract reconstruction during surgery
* steroid hormone medication
* tumours deemed irresectable during liver surgery
* laparoscopic liver surgery

Answer: D