Hepatobiliary Disease
Conditions
Keywords
BiClamp forceps hepatectomy, Clamp crushing technique, Liver parenchyma transection, Randomized controlled trial
Brief summary
The purpose of this study is to compare short-term and long-term efficacy of BiClamp forceps hepatectomy and clamp-crushing technique for parenchymal transection during elective hepatic resection.
Detailed description
Background: Blood loss and the need for blood transfusions during the liver transection have shown to be correlated with higher morbidity and mortality rates and with worsen prognosis. Various devices of liver parenchymal transection have been developed with a view to reducing the intraoperative blood loss. However, to the present there is no randomized controlled trial evaluating the technique of BiClamp forceps during the liver transection. The goal of the present study was to evaluate the safety and effectiveness of BiClamp forceps transection in comparison to the clamp crushing technique in patients offered liver resection. Intervention: One hundred patients with hepatobiliary disease need undergo hepatectomy at Anhui medical university were selected and divided into BiClamp forceps hepatectomy group and clamp-crushing hepatectomy group, each group contains 50 cases. Results: 1. Clinical data include: blood loss during liver transection, total blood loss, blood transfusion, hospital stay, morbidity, mortality, biliary leakage, postoperative liver function, liver transection time, operation time, resection margins, need for portal trial clamping. 2. Statistical method: groups t-test, univariate/multivariate analysis, logistic regression analysis, mixed linear regression and Cox survival analysis were used.
Interventions
PROCEDUREClamp-Crushing technique
Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
DEVICEBiClamp forceps
liver transection during hepatectomy by BiClamp forceps
Sponsors
The First Affiliated Hospital of Anhui Medical University
The Second Hospital of Anhui Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Both male and female, aged 18 or older * Patients scheduled to undergo hepatic resection for some benign or malignant hepatobiliary disease * Child-Pugh class A or B liver function * BiClamp forceps hepatectomy and clamp-crushing feasible based on preoperative imaging * No tumor invasion the main vein, hepatic artery and vein and major inferior vena cava * No extrahepatic metastasis * Voluntary participation in the study, and informed consent.
Exclusion criteria
* Age \<18 years or\> 65 years , pregnant or lactating women * Preoperative liver function evaluation: Child-Pugh C grade * Laparoscopic hepatectomy * Extrahepatic metastasis * Tumor invasion the main vein, hepatic artery and vein and major inferior vena cava * The patient refused to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Total Blood Loss | an expected average of 80 minutes | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 90 days | Operative mortality was defined as any death resulting from a complication during surgery |
| Morbidity | 90 days | — |
| Biliary Leakage | 90 days | Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems |
| Liver Transection Time | an expected average of 40 minutes | liver transection time was calculated from the beginning to the end of the liver resection |
| Number of Participants Requiring a Blood Transfusion | 2 days | Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively |
| Total Bilirubin | 3 postoperative day | serum total bilirubin on 3 postoperative day (umol/L) |
| Duration of Postoperative Hospital Stay | an expected average of 12 days | Time from day of operation to day of discharge |
Countries
China
Participant flow
Recruitment details
Eligibility criteria included scheduled liver resection for benign or malignant hepatobiliary disease and a minimum age of 18 years.
Pre-assignment details
Patients undergoing concomitant vascular resection or bile duct resection and those undergoing emergency liver resection were excluded.
Participants by arm
| Arm | Count |
|---|---|
| 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 electronicknife and blood vessel forceps, but without BiClamp forceps | 43 |
| 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 | 43 |
| Total | 86 |
Baseline characteristics
| Characteristic | Clamp-Crushing Technique | BiClamp Forceps Hepatectomy | Total |
|---|---|---|---|
| Age, Continuous | 53.12 years STANDARD_DEVIATION 10.84 | 55.98 years STANDARD_DEVIATION 11.3 | 54.55 years STANDARD_DEVIATION 11.1 |
| Region of Enrollment China | 43 participants | 43 participants | 86 participants |
| Sex: Female, Male Female | 16 Participants | 23 Participants | 39 Participants |
| Sex: Female, Male Male | 27 Participants | 20 Participants | 47 Participants |
| Specimen weight | 230.73 g STANDARD_DEVIATION 191.35 | 193.25 g STANDARD_DEVIATION 182.48 | 211.99 g STANDARD_DEVIATION 186.82 |
| Transection surface area | 69.11 cm2 STANDARD_DEVIATION 40.09 | 65.16 cm2 STANDARD_DEVIATION 44.3 | 67.14 cm2 STANDARD_DEVIATION 42.04 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 43 | 12 / 43 |
| serious Total, serious adverse events | 4 / 43 | 2 / 43 |
Outcome results
Primary
The Total Blood Loss
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
Time frame: an expected average of 80 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clamp-Crushing Technique | The Total Blood Loss | 376.73 ml | Standard Deviation 303.67 |
| BiClamp Forceps Hepatectomy | The Total Blood Loss | 339.81 ml | Standard Deviation 257.2 |
Secondary
Biliary Leakage
Biliary leakage was documented in line with the International Study Group of Liver Surgery (ISGLS) definitions and grading systems
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clamp-Crushing Technique | Biliary Leakage | 4 participants |
| BiClamp Forceps Hepatectomy | Biliary Leakage | 2 participants |
Secondary
Duration of Postoperative Hospital Stay
Time from day of operation to day of discharge
Time frame: an expected average of 12 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clamp-Crushing Technique | Duration of Postoperative Hospital Stay | 8.65 days | Standard Deviation 2.02 |
| BiClamp Forceps Hepatectomy | Duration of Postoperative Hospital Stay | 8.81 days | Standard Deviation 2.49 |
Secondary
Liver Transection Time
liver transection time was calculated from the beginning to the end of the liver resection
Time frame: an expected average of 40 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clamp-Crushing Technique | Liver Transection Time | 25.51 min | Standard Deviation 12.19 |
| BiClamp Forceps Hepatectomy | Liver Transection Time | 26.21 min | Standard Deviation 17.17 |
Secondary
Morbidity
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clamp-Crushing Technique | Morbidity | 13 participants |
| BiClamp Forceps Hepatectomy | Morbidity | 12 participants |
Secondary
Mortality
Operative mortality was defined as any death resulting from a complication during surgery
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clamp-Crushing Technique | Mortality | 0 participants |
| BiClamp Forceps Hepatectomy | Mortality | 0 participants |
Secondary
Number of Participants Requiring a Blood Transfusion
Administration of blood transfusions is documented for the intraoperative and postoperative period until 48 hours postoperatively
Time frame: 2 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clamp-Crushing Technique | Number of Participants Requiring a Blood Transfusion | 2 participants |
| BiClamp Forceps Hepatectomy | Number of Participants Requiring a Blood Transfusion | 4 participants |
Secondary
Total Bilirubin
serum total bilirubin on 3 postoperative day (umol/L)
Time frame: 3 postoperative day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clamp-Crushing Technique | Total Bilirubin | 17.70 umol/l | Standard Deviation 11.34 |
| BiClamp Forceps Hepatectomy | Total Bilirubin | 18.46 umol/l | Standard Deviation 17.75 |