Trial Outcomes & Findings for Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery (NCT NCT01099475)
NCT ID: NCT01099475
Last Updated: 2014-10-17
Results Overview
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).
COMPLETED
NA
20 participants
L-FABP area under curve from start of surgery up until postoperative day 3
2014-10-17
Participant Flow
Inclusion of participants: Oct 2007 - Jul 2009 Location: Department of Surgery, Maastricht University Medical Centre
Participant milestones
| Measure |
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.
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
|
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
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
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intermittent Pedicle Clamping on Hepatocellular Injury During Liver Surgery
Baseline characteristics by cohort
| Measure |
Pringle Manoeuvre Using 15 Minutes Inflow Occlusion
n=10 Participants
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.
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
|
Pringle Manoeuvre Using 30 Minutes Inflow Occlusion
n=10 Participants
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
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
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64 years
n=5 Participants
|
62 years
n=7 Participants
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) classification
ASA 1
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) classification
ASA 2
|
8 participants
n=5 Participants
|
5 participants
n=7 Participants
|
13 participants
n=5 Participants
|
|
American Society of Anesthesiologists (ASA) classification
ASA 3
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Indication for resection
benign disease
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Indication for resection
malignant disease
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: L-FABP area under curve from start of surgery up until postoperative day 3At 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).
Outcome measures
| Measure |
Pringle Manoeuvre Using 15 Minutes Inflow Occlusion
n=10 Participants
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.
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
|
Pringle Manoeuvre Using 30 Minutes Inflow Occlusion
n=10 Participants
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
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
|
|---|---|---|
|
Hepatocellular Damage Reflected by Liver Fatty-acid Binding Protein (L-FABP) Levels
|
9097 ng*h/mL
Standard Error 1781
|
11,688 ng*h/mL
Standard Error 2247
|
SECONDARY outcome
Timeframe: within 90-days after initial liver surgerymorbidity and mortality occuring after liver surgery graded according to Clavien-Dindo's grading system. In short, any deviation from the postoperative course without the need for pharmacological, radiological or surgical intervention was classified as Clavien-Dindo grade 1; complications requiring pharmacological treatment were graded as grade 2; complications requiring surgical or radiological intervention not under general anesthesia as grade 3a and under general anesthesia as grade 3b; grade 4 complications were life-threatening complications requiring intensive care unit care because of single organ dysfunction (grade 4a) or multiple organ dysfunction (grade 4b); mortality was classed as grade 5.
Outcome measures
| Measure |
Pringle Manoeuvre Using 15 Minutes Inflow Occlusion
n=10 Participants
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.
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
|
Pringle Manoeuvre Using 30 Minutes Inflow Occlusion
n=10 Participants
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
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
|
|---|---|---|
|
Post-resectional Complications
intra-abdominal abscess
|
3 participants
|
2 participants
|
|
Post-resectional Complications
intra-abdominal hemorrhage
|
0 participants
|
1 participants
|
|
Post-resectional Complications
bile leakage
|
4 participants
|
1 participants
|
|
Post-resectional Complications
ascites
|
1 participants
|
0 participants
|
|
Post-resectional Complications
sepsis
|
1 participants
|
2 participants
|
|
Post-resectional Complications
post-resectional liver failure
|
2 participants
|
1 participants
|
|
Post-resectional Complications
30-day mortality
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: at the end of liver surgery, an average of 225 minutesamount of blood in the suction container (and, if applicable, in the weighted gauzes)
Outcome measures
| Measure |
Pringle Manoeuvre Using 15 Minutes Inflow Occlusion
n=10 Participants
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.
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
|
Pringle Manoeuvre Using 30 Minutes Inflow Occlusion
n=10 Participants
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
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
|
|---|---|---|
|
Amount of Blood Loss
|
575 mL
Interval 100.0 to 2300.0
|
450 mL
Interval 250.0 to 1000.0
|
SECONDARY outcome
Timeframe: ALAT area under curve from start of surgery up until postoperative day 3At specific time points before, during and after liver surgery, plasma samples will be obtained to analyse the amount of hepatocellular damage reflected by 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 measures
| Measure |
Pringle Manoeuvre Using 15 Minutes Inflow Occlusion
n=10 Participants
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.
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
|
Pringle Manoeuvre Using 30 Minutes Inflow Occlusion
n=10 Participants
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
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
|
|---|---|---|
|
Hepatocellular Damage Reflected by Alanine Aminotransferase (ALAT) Levels
|
3196 IU*h/L
Standard Error 797
|
3609 IU*h/L
Standard Error 812
|
Adverse Events
Pringle Manoeuvre Using 15 Minutes Inflow Occlusion
Pringle Manoeuvre Using 30 Minutes Inflow Occlusion
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. MAJ van den Broek, MD
Maastricht University Medical Centre
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place