N/A
Completed N=20
Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery
Hepatocellular Injury · Blood Loss
Source: ClinicalTrials.gov NCT01099475 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels — 9097; 11,688 ng*h/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels |
9097; 11,688 | — |
| SECONDARY Post-resectional Complications |
3; 2; 0; 1; 4; 1 | — |
| SECONDARY Amount of Blood Loss |
575; 450 | — |
| SECONDARY Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels |
3196; 3609 | — |
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
Data sourced from ClinicalTrials.gov (NCT01099475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.