Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01099475
First received: April 1, 2010
Last updated: April 5, 2011
Last verified: April 2011
  Purpose

In order to prevent excessive blood loss during liver surgery, an intermittent Pringle manoeuvre 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 intermittent Pringle manoeuvre is unknown. This randomized controlled trial aimed to analyse differences in hepatocellular damage after 15 minutes or 30 minutes intermittent pedicle occlusion during liver surgery for primary or secondary liver tumours.


Condition Intervention
Hepatocellular Injury
Blood Loss
Procedure: no Pringle manoeuvre
Procedure: Pringle manoeuvre using 15 minutes ischemic interval
Procedure: Pringle Manoeuvre using 30 minutes ischemic interval

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Randomized Controlled Trial on the Effect of Intermittent Pedicle Clamping Using 15 or 30 Minutes Ischemic Intervals During Liver Surgery

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • hepatocellular damage [ Time Frame: postoperative day 1 ] [ Designated as safety issue: No ]
    At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by liver fatty-acid binding protein (L-FABP) and alanine aminotransferase (ALAT) level. These timepoints include: baseline (before operation), just before intermittent pedicle clamping, just before end of 15 or 30 minutes pedicle clamping, end of 5 minutes reperfusion, end of liver surgery, 8 hours after start liver surgery, postoperative day 1, 2 and 3


Secondary Outcome Measures:
  • post-resectional complications [ Time Frame: within 90-days after initial liver surgery ] [ Designated as safety issue: No ]
    morbidity and mortality occuring after liver surgery graded according to Clavien-Dindo's grading system

  • amount of blood loss [ Time Frame: at the end of liver surgery ] [ Designated as safety issue: No ]
    amount of blood in the suction container (and, if applicable, in the weighted gauzes)


Enrollment: 30
Study Start Date: October 2007
Study Completion Date: April 2011
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pringle manoeuvre using 15 minutes inflow occlusion
When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.
Procedure: Pringle manoeuvre using 15 minutes ischemic interval
During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion
Experimental: Pringle manoeuvre using 30 minutes inflow occlusion
When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion
Procedure: Pringle Manoeuvre using 30 minutes ischemic interval
During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion
No Intervention: No Pringle manoeuvre
When no intermittent pedicle occlusion during parenchymal transection is necessary, it will be performed without a Pringle Manoeuvre
Procedure: no Pringle manoeuvre
No pedicle clamping will be performed

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients > 18 years of age and < 75 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01099475

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, PO Box 5800, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Cornelis HC Dejong, MD, PhD Maastricht University Medical Centre
  More Information

No publications provided by Maastricht University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. dr. CHC Dejong, Maastricht University Medical Centre
ClinicalTrials.gov Identifier: NCT01099475     History of Changes
Other Study ID Numbers: 06-2-067
Study First Received: April 1, 2010
Last Updated: April 5, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
liver surgery
pringle manoeuvre
hepatocellular damage
surgical complications
patients requiring liver surgery

ClinicalTrials.gov processed this record on September 18, 2014