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

NCT03208192 | Completed Results

• 1 other identifier: MCNC 01/2017
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Transection During Laparoscopic Liver Resection

Keywords

colorectal liver metastases; hepatocellular carcinoma; intrahepatic cholangiocellular carcinoma; tumor of liver; focal nodular hyperplasia liver; hemangioma liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)

  1 day

• Duration of Liver Parenchyma Transaction

  1 day

• Necessity to Apply the Pringle Maneuver.

  1 day

• The Total Duration of Pringle Maneuver.

  1 day

• Hospital Stay (Day)

  up to 1 month

Other Outcomes (1)

• Morbidity

  30 days

Study Arms (2)

ErbeJet

EXPERIMENTAL

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

Procedure: liver transection during laparoscopic liver resection

Misonix

EXPERIMENTAL

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

Interventions

liver transection during laparoscopic liver resection PROCEDURE

liver transection during laparoscopic liver resection

ErbeJet; Misonix

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Moscow Clinical Scientific Center: lead

Study Sites (1)

Moscow Clinical scientific Center

Moscow, Entuziastov Shosse,86, 111123, Russia

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Limitations and Caveats

an addition to the exclusion criteria specified in the design of the study, the latter were expanded due to the following position. This made it difficult to recruit patients to the study.

Results Point of Contact

• Title: Mikhail Efanov, MD, PhD,
• Organization: Moscow Clinical Scientific Center

m.efanov@mknc.ru

+79161058830

Study Officials

• Mikhail Efanov, MD, PhD

  Moscow Clinical Scientific Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinial Research

Model Details: 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)

Study Record Dates

• First Submitted: June 26, 2017
• First Posted: July 5, 2017
• Study Start: February 20, 2017
• Primary Completion: May 20, 2020
• Study Completion: May 20, 2020
• Last Updated: September 24, 2020
• Results First Posted: September 24, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)