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

Moscow Clinical Scientific Center

Status: Completed

Conditions: Liver Transection During Laparoscopic Liver Resection

Treatments: Procedure: liver transection during laparoscopic liver resection

Study type: Interventional

Funder types: Other

Identifiers

NCT03208192

MCNC 01/2017

Details and patient eligibility

About

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

Enrollment: 68 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

ErbeJet

Experimental group

Description:

liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).

Treatment:

Procedure: liver transection during laparoscopic liver resection

Misonix

Experimental group

Description:

liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)

Treatment:

Procedure: liver transection during laparoscopic liver resection