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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03208192
Recruitment Status : Completed
First Posted : July 5, 2017
Results First Posted : September 24, 2020
Last Update Posted : September 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ivan Kazakov, 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


Condition or disease Intervention/treatment Phase
Liver Transection During Laparoscopic Liver Resection Procedure: liver transection during laparoscopic liver resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
Actual Study Start Date : February 20, 2017
Actual Primary Completion Date : May 20, 2020
Actual Study Completion Date : May 20, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Intraoperative Blood Loss [ Time Frame: 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 :
  1. Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2) [ Time Frame: 1 day ]
    Аbsolute measurement of blood loss in relation to resection size (ml/cm^2).

  2. Duration of Liver Parenchyma Transaction [ Time Frame: 1 day ]
    Duration of liver parenchyma transaction (min)

  3. Necessity to Apply the Pringle Maneuver. [ Time Frame: 1 day ]
    the number of participants who needed to apply the Pringle maneuver

  4. The Total Duration of Pringle Maneuver. [ Time Frame: 1 day ]
    The total duration of Pringle maneuver (min)

  5. Hospital Stay (Day) [ Time Frame: up to 1 month ]
    Hospital stay (day)


Other Outcome Measures:
  1. Morbidity [ Time Frame: 30 days ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03208192


Locations
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Russian Federation
Moscow Clinical scientific Center
Moscow, Entuziastov Shosse,86, Russian Federation, 111123
Sponsors and Collaborators
Moscow Clinical Scientific Center
Investigators
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Study Chair: Mikhail Efanov, MD, PhD Moscow Clinical Scientific Center
  Study Documents (Full-Text)

Documents provided by Ivan Kazakov, Moscow Clinical Scientific Center:
Study Protocol  [PDF] February 20, 2017
Informed Consent Form  [PDF] February 20, 2017
Statistical Analysis Plan  [PDF] May 15, 2020

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Responsible Party: Ivan Kazakov, Clinial Research, Moscow Clinical Scientific Center
ClinicalTrials.gov Identifier: NCT03208192    
Other Study ID Numbers: MCNC 01/2017
First Posted: July 5, 2017    Key Record Dates
Results First Posted: September 24, 2020
Last Update Posted: September 24, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan Kazakov, Moscow Clinical Scientific Center:
colorectal liver metastases
hepatocellular carcinoma
intrahepatic cholangiocellular carcinoma
tumor of liver
focal nodular hyperplasia liver
hemangioma liver