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

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

Study Overview

• Status: Completed
• Conditions: Liver Transection During Laparoscopic Liver Resection
• Intervention / Treatment: Procedure: liver transection during laparoscopic liver resection

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Entuziastov Shosse,86
    • Moscow, Entuziastov Shosse,86, Russian Federation, 111123
      • Moscow Clinical Scientific Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ErbeJet; liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).	Procedure: liver transection during laparoscopic liver resection; liver transection during laparoscopic liver resection
Experimental: Misonix; 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; liver transection during laparoscopic liver resection

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Collaborators and Investigators

• Sponsor: Moscow Clinical Scientific Center
• Investigators: Study Chair: Mikhail Efanov, MD, PhD, Moscow Clinical Scientific Center

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2017
• Primary Completion (Actual): May 20, 2020
• Study Completion (Actual): May 20, 2020

Study Registration Dates

• First Submitted: June 26, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 2, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: hepatocellular carcinoma; intrahepatic cholangiocellular carcinoma; colorectal liver metastases; tumor of liver; focal nodular hyperplasia liver; hemangioma liver
• Other Study ID Numbers: MCNC 01/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No