Liver Transection During Laparoscopic Liver ResectionLLSNCT03208192

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

A study testing liver transection during laparoscopic liver resection in people with Liver Transection During Laparoscopic Liver Resection, run by Moscow Clinical Scientific Center at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Liver Transection During Laparoscopic Liver Resection
What is being tested?: liver transection during laparoscopic liver resection
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 68 participants
Where: 1 siteRussia
Study dates: 20 Feb 2017to 20 May 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

• 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

Show all 13Show fewer

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 locations and contacts

1 site in 1 country.

Russia1 site

Moscow Clinical scientific Center
Moscow, Entuziastov Shosse,86, 111123

Other trials in Russia

About this study

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
Being tested: liver transection during laparoscopic liver resection
Keywords: colorectal liver metastases, hepatocellular carcinoma, intrahepatic cholangiocellular carcinoma, tumor of liver, focal nodular hyperplasia liver, hemangioma liver
Medical subject headings: Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

liver transection during laparoscopic liver resectionProcedure or surgery
liver transection during laparoscopic liver resection

Study groups in NCT03208192
Study group	Role	What they receive
ErbeJet	Experimental	liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). Receives: 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) Receives: Procedure: liver transection during laparoscopic liver resection

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 day

Secondary outcomes (5)

Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)
Аbsolute measurement of blood loss in relation to resection size (ml/cm^2).
Measured: 1 day
Duration of Liver Parenchyma Transaction
Duration of liver parenchyma transaction (min)
Measured: 1 day
Necessity to Apply the Pringle Maneuver.
the number of participants who needed to apply the Pringle maneuver
Measured: 1 day
The Total Duration of Pringle Maneuver.
The total duration of Pringle maneuver (min)
Measured: 1 day
Hospital Stay (Day)
Hospital stay (day)
Measured: up to 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201720 May 2020

First posted5 Jul 2017
Study start20 Feb 2017
Primary completion20 May 2020
Study completion20 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Liver Transection During Laparoscopic Liver ResectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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)
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03208192
Sponsor's protocol ID: MCNC 01/2017
Acronym: LLS
Status last verified: Sep 2020
First submitted: 26 Jun 2017
Last updated: 24 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
ClinicalTrials.gov ID: NCT03208192
Acronym / sponsor ID: LLS / MCNC 01/2017
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
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Moscow Clinical Scientific CenterUniversity, hospital or other
Study start: 20 Feb 2017 (actual)
Primary completion: 20 May 2020 (actual)
Study completion: 20 May 2020 (actual)
First posted: 5 Jul 2017 (actual)
Results: Posted 24 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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)

Arm	Type	Receives
ErbeJet	Experimental	Procedure: liver transection during laparoscopic liver resectionliver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).
Misonix	Experimental	Procedure: liver transection during laparoscopic liver resectionliver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (13 listed)

• Difficulty index > 12 points (see below)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
liver transection during laparoscopic liver resectionliver transection during laparoscopic liver resection	Procedure or surgery	ErbeJet, Misonix

Primary outcome

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.

5 secondary outcomes

Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)
Time frame: 1 day
Duration of Liver Parenchyma Transaction
Time frame: 1 day
Necessity to Apply the Pringle Maneuver.
Time frame: 1 day
The Total Duration of Pringle Maneuver.
Time frame: 1 day
Hospital Stay (Day)
Time frame: up to 1 month

Results and safety

Results posted to the registry on 24 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ErbeJet	32	32
Misonix	36	36

Primary outcome: Intraoperative Blood Loss

Time frame: 1 day. Mean (Full Range). Unit: ml

Measure	ErbeJet n = 32	Misonix n = 36
Value	195 (10 to 400)	218 (10 to 1400)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 30 days after the operation. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ErbeJet	2 of 32 (6.3%)	2 of 32 (6.3%)	0 of 32
Misonix	2 of 36 (5.6%)	2 of 36 (5.6%)	0 of 36

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mikhail Efanov, MD, PhD study chair

Moscow Clinical Scientific Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative Blood Loss (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03208192.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.