Liver Transection During Laparoscopic Liver Resection
Conditions
Keywords
colorectal liver metastases, hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, tumor of liver, focal nodular hyperplasia liver, hemangioma liver
Brief summary
Background: until now, there is no agreement about the safest and feasible method for liver parenchyma transection during laparoscopic liver resection. Study design: prospective, randomized, single-center The purpose of the study: comparison of short-term results of two methods of parenchyma liver transection during laparoscopic liver resection
Interventions
PROCEDUREliver transection during laparoscopic liver resection
liver transection during laparoscopic liver resection
Sponsors
Moscow Clinical Scientific Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two groups will be compared. Group 1: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). Group 2: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with benign lesions (hemangioma, focal nodular hyperplasia \[FNH\], hepatocellular adenoma, biliary cystadenoma, hydatid echinococcosis \[only with total pericystectomy\]) and malignant tumors (colorectal cancer metastases in the liver \[CRLM\], hepatocellular carcinoma \[HCC\], intrahepatic cholangiocellular carcinoma, gallbladder cancer T1b-3NxMo without invasion into bile ducts and adjacent organs), which involves laparoscopic segmental or major resection of the liver. * Gender: both, male and female * Minimum age 18 years * Maximum age: 80 years * ASA physical status I-IV * BMI up to 40 kg/m2 * No simultaneous extrahepatic intra-abdominal procedures (bile duct resection, colon resection, partial duodenum resection) * Total bilirubin up to 100mmol/l if jaundice presents in non-cirrhotic patients * If cirrhosis is present, class A and B according to CTP score
Exclusion criteria
* • Difficulty index \> 12 points (see below) * Tumor invasion of IVC or portal trunk (necessity of vascular reconstruction) * Repeated liver resection before laparoscopic resection (the single resection before is not a contraindication) * Simultaneous extra-hepatic intra-abdominal procedures (bile duct resection, colon resection etc.) * Age under 18 years * Age above 80 years * ASA physical status \>IV * BMI \> 40 kg/m2 * Total bilirubin \>100mmol/l if jaundice presents in non-cirrhotic patients * If cirrhosis is present, class C according to CTP score * Persons who are incapable of giving consent * Pregnant or breast-feeding women * Patients enlisted in other studies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative Blood Loss | 1 day | Absolute blood loss (ml) will be calculated as the amount of blood (collected only during the parenchyma resection) in suction the container after the subtraction of all irrigating fluids and weighing operative sponges. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2) | 1 day | Аbsolute measurement of blood loss in relation to resection size (ml/cm\^2). |
| Duration of Liver Parenchyma Transaction | 1 day | Duration of liver parenchyma transaction (min) |
| The Total Duration of Pringle Maneuver. | 1 day | The total duration of Pringle maneuver (min) |
| Hospital Stay (Day) | up to 1 month | Hospital stay (day) |
| Necessity to Apply the Pringle Maneuver. | 1 day | the number of participants who needed to apply the Pringle maneuver |
Other
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 30 days | Morbidity according to Clavien-Dindo classification (it is advisable to activate complications class II-V). The Clavien-Dindo classification (CDC) is a standardized system for the registration of surgical complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The major characteristic of the CDC system is that the severity of a complication is graded based on the type of therapy required to treat the complication. The CDC system has been validated and accepted worldwide for use in many fields of surgery. The complications that change the treatment of grade II-V. |
Countries
Russia
Participant flow
Recruitment details
Partipants were recruited at Moscow Clinical Scientific Center. The first participant was enrolled on Feb 2017 and the last participant was enrolled in April 2020
Pre-assignment details
Of 68 enrolled participants, met inlusion criteria and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| ErbeJet liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection | 32 |
| Misonix liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection | 36 |
| Total | 68 |
Baseline characteristics
| Characteristic | Misonix | Total | ErbeJet |
|---|---|---|---|
| Age, Continuous | 54 years STANDARD_DEVIATION 15 | 55 years STANDARD_DEVIATION 14 | 56 years STANDARD_DEVIATION 14 |
| Body mass index (BMI) | 30 kg/m^2 STANDARD_DEVIATION 5.2 | 29 kg/m^2 STANDARD_DEVIATION 6.1 | 28.4 kg/m^2 STANDARD_DEVIATION 6.9 |
| Difficulty index score (IWATE Criteria) Low\Intermediate\Advanced\Expert | 7 units on a scale | 7 units on a scale | 7 units on a scale |
| Malignant/benign lesions Bening | 12 Participants | 26 Participants | 14 Participants |
| Malignant/benign lesions Malignant | 24 Participants | 42 Participants | 18 Participants |
| Physical status classification system (ASA) ASA 1 | 4 Participants | 7 Participants | 3 Participants |
| Physical status classification system (ASA) ASA 2 | 20 Participants | 35 Participants | 15 Participants |
| Physical status classification system (ASA) ASA 3 | 12 Participants | 26 Participants | 14 Participants |
| Postero-superior segments | 20 Participants | 36 Participants | 16 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Sex: Female, Male Female | 21 Participants | 41 Participants | 20 Participants |
| Sex: Female, Male Male | 15 Participants | 27 Participants | 12 Participants |
| Tumor size (mm) | 51 mm | 61 mm | 71 mm |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 36 |
| other Total, other adverse events | 2 / 32 | 2 / 36 |
| serious Total, serious adverse events | 2 / 32 | 2 / 36 |
Outcome results
Primary
Intraoperative Blood Loss
Absolute blood loss (ml) will be calculated as the amount of blood (collected only during the parenchyma resection) in suction the container after the subtraction of all irrigating fluids and weighing operative sponges.
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ErbeJet | Intraoperative Blood Loss | 195 ml |
| Misonix | Intraoperative Blood Loss | 218 ml |
Secondary
Duration of Liver Parenchyma Transaction
Duration of liver parenchyma transaction (min)
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ErbeJet | Duration of Liver Parenchyma Transaction | 107 min |
| Misonix | Duration of Liver Parenchyma Transaction | 100 min |
Secondary
Hospital Stay (Day)
Hospital stay (day)
Time frame: up to 1 month
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ErbeJet | Hospital Stay (Day) | 8 day |
| Misonix | Hospital Stay (Day) | 8 day |
Secondary
Necessity to Apply the Pringle Maneuver.
the number of participants who needed to apply the Pringle maneuver
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ErbeJet | Necessity to Apply the Pringle Maneuver. | 15 participants |
| Misonix | Necessity to Apply the Pringle Maneuver. | 21 participants |
Secondary
The Total Duration of Pringle Maneuver.
The total duration of Pringle maneuver (min)
Time frame: 1 day
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ErbeJet | The Total Duration of Pringle Maneuver. | 23 min |
| Misonix | The Total Duration of Pringle Maneuver. | 18 min |
Secondary
Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)
Аbsolute measurement of blood loss in relation to resection size (ml/cm\^2).
Time frame: 1 day
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ErbeJet | Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2) | 3.9 ml/cm^2 |
| Misonix | Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2) | 5 ml/cm^2 |
Other Pre-specified
Morbidity
Morbidity according to Clavien-Dindo classification (it is advisable to activate complications class II-V). The Clavien-Dindo classification (CDC) is a standardized system for the registration of surgical complications. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). The major characteristic of the CDC system is that the severity of a complication is graded based on the type of therapy required to treat the complication. The CDC system has been validated and accepted worldwide for use in many fields of surgery. The complications that change the treatment of grade II-V.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ErbeJet | Morbidity | 2 Participants |
| Misonix | Morbidity | 2 Participants |