Trial Outcomes & Findings for Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial (NCT NCT02197481)
NCT ID: NCT02197481
Last Updated: 2017-12-14
Results Overview
Blood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
105 participants
Primary outcome timeframe
an expected average of 80 minutes
Results posted on
2017-12-14
Participant Flow
Eligibility criteria included scheduled liver resection for benign or malignant hepatobiliary disease and a minimum age of 18 years.
Patients undergoing concomitant vascular resection or bile duct resection and those undergoing emergency liver resection were excluded.
Participant milestones
| Measure |
Clamp-Crushing Technique
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electric knife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Overall Study
STARTED
|
43
|
43
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Usefulness of BiClamp Forceps for Liver Resection: A Randomized Clinical Trial
Baseline characteristics by cohort
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.12 years
STANDARD_DEVIATION 10.84 • n=5 Participants
|
55.98 years
STANDARD_DEVIATION 11.30 • n=7 Participants
|
54.55 years
STANDARD_DEVIATION 11.10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
43 participants
n=5 Participants
|
43 participants
n=7 Participants
|
86 participants
n=5 Participants
|
|
Transection surface area
|
69.11 cm2
STANDARD_DEVIATION 40.09 • n=5 Participants
|
65.16 cm2
STANDARD_DEVIATION 44.30 • n=7 Participants
|
67.14 cm2
STANDARD_DEVIATION 42.04 • n=5 Participants
|
|
Specimen weight
|
230.73 g
STANDARD_DEVIATION 191.35 • n=5 Participants
|
193.25 g
STANDARD_DEVIATION 182.48 • n=7 Participants
|
211.99 g
STANDARD_DEVIATION 186.82 • n=5 Participants
|
PRIMARY outcome
Timeframe: an expected average of 80 minutesBlood loss during operation. Blood loss was calculated from the beginning to the end of operation The amount of blood loss was measured from the suction volume after subtraction of rinse fluids and from the weight of soaked gauzes that were used during transection
Outcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
The Total Blood Loss
|
376.73 ml
Standard Deviation 303.67
|
339.81 ml
Standard Deviation 257.20
|
SECONDARY outcome
Timeframe: an expected average of 40 minutesliver transection time was calculated from the beginning to the end of the liver resection
Outcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Liver Transection Time
|
25.51 min
Standard Deviation 12.19
|
26.21 min
Standard Deviation 17.17
|
SECONDARY outcome
Timeframe: 90 daysOperative mortality was defined as any death resulting from a complication during surgery
Outcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Mortality
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Morbidity
|
13 participants
|
12 participants
|
SECONDARY outcome
Timeframe: 90 daysBiliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
Outcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Biliary Leakage
|
4 participants
|
2 participants
|
SECONDARY outcome
Timeframe: an expected average of 12 daysTime from day of operation to day of discharge
Outcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Duration of Postoperative Hospital Stay
|
8.65 days
Standard Deviation 2.02
|
8.81 days
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: 2 daysAdministration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively
Outcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Number of Participants Requiring a Blood Transfusion
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 3 postoperative dayserum total bilirubin on 3 postoperative day (umol/L)
Outcome measures
| Measure |
Clamp-Crushing Technique
n=43 Participants
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 Participants
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Total Bilirubin
|
17.70 umol/l
Standard Deviation 11.34
|
18.46 umol/l
Standard Deviation 17.75
|
Adverse Events
Clamp-Crushing Technique
Serious events: 4 serious events
Other events: 12 other events
Deaths: 0 deaths
BiClamp Forceps Hepatectomy
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clamp-Crushing Technique
n=43 participants at risk
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 participants at risk
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
Hepatobiliary disorders
biliary leakage
|
7.0%
3/43 • Number of events 43
|
2.3%
1/43 • Number of events 43
|
|
General disorders
pleural effusions
|
2.3%
1/43 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
Other adverse events
| Measure |
Clamp-Crushing Technique
n=43 participants at risk
liver transection during hepatectomy by the routine clamp-crushing technical without BiClamp forceps assisted
Clamp-Crushing technique: Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
|
BiClamp Forceps Hepatectomy
n=43 participants at risk
The BiClamp forceps, a reusable bipolar sealing instrument for use in open surgery, was uniformly employed in all patients randomized to BiClamp forcep hepatectomy group in the present study.
BiClamp forceps: liver transection during hepatectomy by BiClamp forceps
|
|---|---|---|
|
General disorders
pleural effusions
|
16.3%
7/43 • Number of events 7
|
16.3%
7/43 • Number of events 7
|
|
Hepatobiliary disorders
Liver failure
|
4.7%
2/43 • Number of events 2
|
4.7%
2/43 • Number of events 2
|
|
Infections and infestations
Wound infection
|
4.7%
2/43 • Number of events 2
|
4.7%
2/43 • Number of events 2
|
|
Hepatobiliary disorders
Biliary leakage
|
2.3%
1/43 • Number of events 1
|
2.3%
1/43 • Number of events 1
|
Additional Information
Dr.Jiang-ming Chen
The Second Affiliated Hospital of Anhui Medical University
Phone: 15855518651
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place