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

Not Applicable

Completed

• Conditions: Liver Transection During Laparoscopic Liver Resection
• Interventions: Procedure: liver transection during laparoscopic liver resection

• Registration Number: NCT03208192
• Lead Sponsor: Moscow Clinical Scientific Center

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-20
• Study First Submitted: 2017-06-26
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-05
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-20
• Results First Submitted: 2020-06-04
• Status Verified: 2020-09
• Results First Submitted QC: 2020-09-02
• Last Update Submitted: 2020-09-02
• Results First Posted: 2020-09-24
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misonix	liver transection during laparoscopic liver resection	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
ErbeJet	liver transection during laparoscopic liver resection	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Necessity to Apply the Pringle Maneuver.	1 day	the number of participants who needed to apply the Pringle maneuver
Hospital Stay (Day)	up to 1 month	Hospital stay (day)
The Total Duration of Pringle Maneuver.	1 day	The total duration of Pringle maneuver (min)

Trial Locations

Locations (1)

Moscow Clinical scientific Center; 🇷🇺 Moscow, Entuziastov Shosse,86, Russian Federation