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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ErbeJet | Experimental | liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). |
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| Misonix | Experimental | liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| liver transection during laparoscopic liver resection | Procedure | liver transection during laparoscopic liver resection |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 day |
| Duration of Liver Parenchyma Transaction |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | 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. |
Inclusion Criteria:
Exclusion Criteria:
• Difficulty index > 12 points (see below)
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| Name | Affiliation | Role |
|---|---|---|
| Mikhail Efanov, MD, PhD | Moscow Clinical Scientific Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Clinical scientific Center | Moscow | Entuziastov Shosse,86 | 111123 | Russia |
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Of 68 enrolled participants, met inlusion criteria and were randomized.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | ErbeJet | liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2). |
| FG001 | Misonix | liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2017 | Jun 2, 2020 |
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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)
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Duration of liver parenchyma transaction (min)
| 1 day |
| Necessity to Apply the Pringle Maneuver. | the number of participants who needed to apply the Pringle maneuver | 1 day |
| The Total Duration of Pringle Maneuver. | The total duration of Pringle maneuver (min) | 1 day |
| Hospital Stay (Day) | Hospital stay (day) | up to 1 month |
| 30 days |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | ErbeJet | 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 |
| BG001 | Misonix | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Body mass index (BMI) | Median | Standard Deviation | kg/m^2 |
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| Physical status classification system (ASA) | ASA 1: A normal healthy patient. ASA 2: A patient with a mild systemic disease. ASA 3: A patient with a severe systemic disease that is not life-threatening. ASA 4: A patient with a severe systemic disease that is a constant threat to life. ASA 5: A moribund patient who is not expected to survive without the operation. The patient is not expected to survive beyond the next 24 hours without surgery. ASA 6: A brain-dead patient whose organs are being removed with the intention of transplanting them into another patient. | Count of Participants | Participants |
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| Malignant/benign lesions | Count of Participants | Participants |
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| Tumor size (mm) | Median | Full Range | mm |
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| Postero-superior segments | Count of Participants | Participants |
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| Difficulty index score (IWATE Criteria) Low\Intermediate\Advanced\Expert | IWATE criteria proposed at the International Consensus Conference on Laparoscopic Liver Resection as difficulty scoring system for laparoscopic liver resection. Difficulty index includes the type of liver resection (partial resection, segmentectomy, and sectionectomy), the size and topography of the tumor, its proximity to the large vessels of the liver, the presence and stage of liver cirrhosis (CTP) and has a scale ranging from 0 to 12. Difficalty level: low 0-4, intermediate 4-6, advanced 7-9, expert 10-12. | Median | Full Range | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | ml | 1 day |
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| Secondary | 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). | Posted | Mean | Full Range | ml/cm^2 | 1 day |
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| Secondary | Duration of Liver Parenchyma Transaction | Duration of liver parenchyma transaction (min) | Posted | Median | Full Range | min | 1 day |
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| Secondary | Necessity to Apply the Pringle Maneuver. | the number of participants who needed to apply the Pringle maneuver | Posted | Number | participants | 1 day |
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| Secondary | The Total Duration of Pringle Maneuver. | The total duration of Pringle maneuver (min) | Posted | Median | Full Range | min | 1 day |
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| Secondary | Hospital Stay (Day) | Hospital stay (day) | Posted | Mean | Full Range | day | up to 1 month |
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| Other Pre-specified | Morbidity | 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. | Posted | Count of Participants | Participants | 30 days |
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30 days after the operation
The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ErbeJet | 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 | 0 | 32 | 2 | 32 | 2 | 32 |
| EG001 | Misonix | 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 | 0 | 36 | 2 | 36 | 2 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fluid accumulation | Hepatobiliary disorders | Non-systematic Assessment | postoperative fluid accumulation in the area of liver resection. Percutaneous puncture treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| fluid collection | Surgical and medical procedures | Non-systematic Assessment | liquid accumulation along the line of liver resection that required percutaneous puncture |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mikhail Efanov, MD, PhD, | Moscow Clinical Scientific Center | +79161058830 | m.efanov@mknc.ru |
| Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 20, 2017 | Jun 2, 2020 | ICF_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2020 | Jun 4, 2020 | SAP_002.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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