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

• Sponsor: Moscow Clinical Scientific Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03208192
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Actual Duration (Months): 38.9
• Patients Per Site Per Month: 1.7

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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)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: Feb 20, 2017
• Actual Primary Completion Date: May 20, 2020
• Actual Study Completion Date: May 20, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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).

2. Duration of Liver Parenchyma Transaction [1 day]

   Duration of liver parenchyma transaction (min)

3. Necessity to Apply the Pringle Maneuver. [1 day]

   the number of participants who needed to apply the Pringle maneuver

4. The Total Duration of Pringle Maneuver. [1 day]

   The total duration of Pringle maneuver (min)

5. Hospital Stay (Day) [up to 1 month]

   Hospital stay (day)

Other Outcome Measures

1. Morbidity [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moscow Clinical scientific Center	Moscow	Entuziastov Shosse,86	Russian Federation	111123

Sponsors and Collaborators

• Moscow Clinical Scientific Center

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Feb 20, 2017
• Informed Consent Form - Feb 20, 2017
• Statistical Analysis Plan - May 15, 2020

More Information

Publications

None provided.

• Responsible Party: Ivan Kazakov, Clinial Research, Moscow Clinical Scientific Center
• ClinicalTrials.gov Identifier: NCT03208192
• Other Study ID Numbers: MCNC 01/2017
• First Posted: Jul 5, 2017
• Last Update Posted: Sep 24, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Ivan Kazakov, Clinial Research, Moscow Clinical Scientific Center: colorectal liver metastases; hepatocellular carcinoma; intrahepatic cholangiocellular carcinoma; tumor of liver; focal nodular hyperplasia liver; hemangioma liver

Study Results

Participant Flow

Recruitment Details	Partipants were recruited at Moscow Clinical Scientific Center. The first participant was enrolled on Feb 2017 and the last participant was enrolled in April 2020
Pre-assignment Detail	Of 68 enrolled participants, met inlusion criteria and were randomized.

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
Period Title: Overall Study
STARTED	32	36
COMPLETED	32	36
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	ErbeJet	Misonix	Total
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). liver transection during laparoscopic liver resection: 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) liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection	Total of all reporting groups
Overall Participants	32	36	68
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56 (14)	54 (15)	55 (14)
Sex: Female, Male (Count of Participants)
Female	20 62.5%	21 58.3%	41 60.3%
Male	12 37.5%	15 41.7%	27 39.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Body mass index (BMI) (kg/m^2) [Median (Standard Deviation) ]
Median (Standard Deviation) [kg/m^2]	28.4 (6.9)	30 (5.2)	29 (6.1)
Physical status classification system (ASA) (Count of Participants)
ASA 1	3 9.4%	4 11.1%	7 10.3%
ASA 2	15 46.9%	20 55.6%	35 51.5%
ASA 3	14 43.8%	12 33.3%	26 38.2%
Malignant/benign lesions (Count of Participants)
Malignant	18 56.3%	24 66.7%	42 61.8%
Bening	14 43.8%	12 33.3%	26 38.2%
Tumor size (mm) (mm) [Median (Full Range) ]
Median (Full Range) [mm]	71	51	61
Postero-superior segments (Count of Participants)
Count of Participants [Participants]	16 50%	20 55.6%	36 52.9%
Difficulty index score (IWATE Criteria) Low\Intermediate\Advanced\Expert (units on a scale) [Median (Full Range) ]
Median (Full Range) [units on a scale]	7	7	7

Outcome Measures

1. Primary Outcome

Title	Intraoperative Blood Loss
Description	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.
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
Measure Participants	32	36
Mean (Full Range) [ml]	195	218

2. Secondary Outcome

Title	Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)
Description	Аbsolute measurement of blood loss in relation to resection size (ml/cm^2).
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
Measure Participants	32	36
Mean (Full Range) [ml/cm^2]	3.9	5

3. Secondary Outcome

Title	Duration of Liver Parenchyma Transaction
Description	Duration of liver parenchyma transaction (min)
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)
Measure Participants	32	36
Median (Full Range) [min]	107	100

4. Secondary Outcome

Title	Necessity to Apply the Pringle Maneuver.
Description	the number of participants who needed to apply the Pringle maneuver
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). liver transection during laparoscopic liver resection: 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) liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
Measure Participants	32	36
Number [participants]	15 46.9%	21 58.3%

5. Secondary Outcome

Title	The Total Duration of Pringle Maneuver.
Description	The total duration of Pringle maneuver (min)
Time Frame	1 day

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). liver transection during laparoscopic liver resection: 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) liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
Measure Participants	32	36
Median (Full Range) [min]	23	18

6. Secondary Outcome

Title	Hospital Stay (Day)
Description	Hospital stay (day)
Time Frame	up to 1 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). liver transection during laparoscopic liver resection: 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) liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
Measure Participants	32	36
Mean (Full Range) [day]	8	8

7. Other Pre-specified Outcome

Title	Morbidity
Description	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.
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	ErbeJet	Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). liver transection during laparoscopic liver resection: 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) liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
Measure Participants	32	36
Count of Participants [Participants]	2 6.3%	2 5.6%

Adverse Events

Time Frame	30 days after the operation
Adverse Event Reporting Description	The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions
Arm/Group Title	ErbeJet		Misonix
Arm/Group Description	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). liver transection during laparoscopic liver resection: 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) liver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection
All Cause Mortality
	ErbeJet		Misonix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/36 (0%)
Serious Adverse Events
	ErbeJet		Misonix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/32 (6.3%)		2/36 (5.6%)
Hepatobiliary disorders
fluid accumulation	2/32 (6.3%)	2	2/36 (5.6%)	2
Other (Not Including Serious) Adverse Events
	ErbeJet		Misonix
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/32 (6.3%)		2/36 (5.6%)
Surgical and medical procedures
fluid collection	2/32 (6.3%)	2	2/36 (5.6%)	2

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.