Clinical trial NCT01099475: Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery
Official title: Randomized Controlled Trial on the Effect of Intermittent Pedicle Clamping Using 15 or 30 Minutes Ischemic Intervals During Liver Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Injury
Blood Loss
Keywords: liver surgery
pringle manoeuvre
hepatocellular damage
surgical complications
patients requiring liver surgery
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2010-04-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Surgical procedure Patients were anaesthetized using isoflurane and propofol. They routinely had an epidural catheter, urinary catheter, two peripheral venous catheters and indwelling catheters in a jugular vein and radial artery. Body temperature was maintained using a Bair Hugger system (Arizant Healthcare Inc. Eden Prairie, Minnesota).

The surgical procedure was performed using a subcostal bilateral incision and Olivier retractors to improve exposure. After dissection of the teres hepatis ligament, the liver was mobilized. Thereafter, an intra-operative ultrasound was performed to define the position of the tumour in relation to vascular and biliary structures. As IPM was not routinely applied, a patient was randomized for 15 minted IPM (15IPM) or 30 minutes IPM (30IPM) only after the surgeon had decided a complete Pringle manoeuvre would be required. During 15IPM or 30IPM, the complete portal triad was clamped using a rubber sling. The time of inflow occlusion was adapted to the need according to the randomization protocol. Occasionally, the left or right pedicle was ligated after protocolled IPM. Five minutes reperfusion intervals were applied during which transection was stopped and cut surfaces were gently compressed to ensure hemostasis. A Cavitron Ultrasonic Surgical Aspirator (CUSA system 200 macrodissector, Cavitron Surgical Systems, Stamford, Connecticut) and Argon beam coagulation (Force GSU System, Valleylab, Boulder, Colorado) were used for liver transection. A stapler device or clamps were used for transection of the hepatic veins. Central venous pressure was maintained below 5 centimetre of water (cm H2O) during transection to reduce venous back-bleeding. After surgery, the weight of the resection specimen was recorded. Perioperative care was protocolled, as described earlier.

Eligibility criteria: 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

Primary outcomes:
measure: Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels
timeFrame: L-FABP area under curve from start of surgery up until postoperative day 3
Secondary outcomes:
measure: Post-resectional Complications
timeFrame: within 90-days after initial liver surgery
measure: Amount of Blood Loss
timeFrame: at the end of liver surgery, an average of 225 minutes
measure: Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels
timeFrame: ALAT area under curve from start of surgery up until postoperative day 3
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
state: PO Box 5800
Study officials:
affiliation: Maastricht University Medical Centre
name: Cornelis HC Dejong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Broek MA, Bloemen JG, Dello SA, van de Poll MC, Olde Damink SW, Dejong CH. Randomized controlled trial analyzing the effect of 15 or 30 min intermittent Pringle maneuver on hepatocellular damage during liver surgery. J Hepatol. 2011 Aug;55(2):337-45. doi: 10.1016/j.jhep.2010.11.024. Epub 2010 Dec 13.
citation: Dello SA, Reisinger KW, van Dam RM, Bemelmans MH, van Kuppevelt TH, van den Broek MA, Olde Damink SW, Poeze M, Buurman WA, Dejong CH. Total intermittent Pringle maneuver during liver resection can induce intestinal epithelial cell damage and endotoxemia. PLoS One. 2012;7(1):e30539. doi: 10.1371/journal.pone.0030539. Epub 2012 Jan 24.