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Randomized Controlled Trial on the Effect of Intermittent Pedicle Clamping Using 15 or 30 Minutes Ischemic Intervals During Liver Surgery


N/A
18 Years
75 Years
Not Enrolling
Both
Hepatocellular Injury, Blood Loss

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Trial Information

Randomized Controlled Trial on the Effect of Intermittent Pedicle Clamping Using 15 or 30 Minutes Ischemic Intervals During Liver Surgery


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Outcome Measure:

hepatocellular damage

Outcome Description:

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

Outcome Time Frame:

postoperative day 1

Safety Issue:

No

Principal Investigator

Cornelis HC Dejong, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Maastricht University Medical Centre

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

06-2-067

NCT ID:

NCT01099475

Start Date:

October 2007

Completion Date:

April 2011

Related Keywords:

  • Hepatocellular Injury
  • Blood Loss
  • liver surgery
  • pringle manoeuvre
  • hepatocellular damage
  • surgical complications
  • patients requiring liver surgery
  • Hemorrhage
  • Liver Diseases

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