Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery

NCT01099475 | Completed Results

• 1 other identifier: 06-2-067
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Injury; Blood Loss

Keywords

liver surgery; pringle manoeuvre; hepatocellular damage; surgical complications; patients requiring liver surgery

Outcome Measures

Primary Outcomes (1)

• Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels

  At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by L-FABP) 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. This continuous variable with repeated measurements was summarized as area under the curve (AUC) from baseline to postoperative day 3 (as described in Matthews JN, Altman DG, Campbell MJ, Royston P. Analysis of serial measurements in medical research. Bmj 1990;300:230-5).

  L-FABP area under curve from start of surgery up until postoperative day 3

Secondary Outcomes (3)

• Post-resectional Complications

  within 90-days after initial liver surgery

• Amount of Blood Loss

  at the end of liver surgery, an average of 225 minutes

• Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels

  ALAT area under curve from start of surgery up until postoperative day 3

Study Arms (2)

Pringle manoeuvre 15 minutes

EXPERIMENTAL

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. During inflow occlusion, the complete portal triad was clamped using a rubber sling.

Procedure: Pringle manoeuvre 15 minutes

Pringle manoeuvre 30 minutes

EXPERIMENTAL

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. During inflow occlusion, the complete portal triad was clamped using a rubber sling.

Procedure: Pringle manoeuvre 30 minutes

Interventions

Pringle manoeuvre 15 minutes PROCEDURE

During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion

Pringle manoeuvre 15 minutes

Pringle manoeuvre 30 minutes PROCEDURE

During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion

Pringle manoeuvre 30 minutes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, PO Box 5800, 6202 AZ, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 21147188 RESULT

• 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.

  PMID: 22291982 RESULT

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. MAJ van den Broek, MD
• Organization: Maastricht University Medical Centre

m.vandenbroek@maastrichtuniversity.nl

31 43 3884502

Study Officials

• Cornelis HC Dejong, MD, PhD

  Maastricht University Medical Centre

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 7, 2010
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: April 1, 2011
• Last Updated: October 17, 2014
• Results First Posted: October 17, 2014

Record last verified: 2014-10

Locations

NL (1)