Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection

Study Overview
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Brief Summary
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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

Official Title
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Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection

Conditions
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Liver Transection During Laparoscopic Liver Resection

Intervention / Treatment
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* Procedure: liver transection during laparoscopic liver resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ErbeJet<br>liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). | Procedure: liver transection during laparoscopic liver resection<br>* liver transection during laparoscopic liver resection<br>|
| Experimental: Misonix<br>liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System) | Procedure: liver transection during laparoscopic liver resection<br>* liver transection during laparoscopic liver resection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 day | 
| Duration of Liver Parenchyma Transaction | Duration of liver parenchyma transaction (min) | 1 day | 
| Necessity to Apply the Pringle Maneuver. | the number of participants who needed to apply the Pringle maneuver | 1 day | 
| The Total Duration of Pringle Maneuver. | The total duration of Pringle maneuver (min) | 1 day | 
| Hospital Stay (Day) | Hospital stay (day) | up to 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal liver metastases, hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, tumor of liver, focal nodular hyperplasia liver, hemangioma liver