Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-25 @ 6:36 PM
Study NCT ID:
NCT03208192
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2017-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
Sponsor:
Organization:
Raw JSON
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This made it difficult to recruit patients to the study.'}}, 'adverseEventsModule': {'timeFrame': '30 days after the operation', 'description': 'The definition of adverse event, used to collect adverse event information, no differs from the clinicaltrials.gov Definitions', 'eventGroups': [{'id': 'EG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 2, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 2, 'seriousNumAtRisk': 36, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'fluid collection', 'notes': 'liquid accumulation along the line of liver resection that required percutaneous puncture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'fluid accumulation', 'notes': 'postoperative fluid accumulation in the area of liver resection. Percutaneous puncture treatment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 32, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intraoperative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).'}, {'id': 'OG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)'}], 'classes': [{'categories': [{'measurements': [{'value': '195', 'groupId': 'OG000', 'lowerLimit': '10', 'upperLimit': '400'}, {'value': '218', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '1400'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', '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.', 'unitOfMeasure': 'ml', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).'}, {'id': 'OG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)'}], 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000', 'lowerLimit': '0.9', 'upperLimit': '10.6'}, {'value': '5', 'groupId': 'OG001', 'lowerLimit': '0.4', 'upperLimit': '20'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 day', 'description': 'Аbsolute measurement of blood loss in relation to resection size (ml/cm\\^2).', 'unitOfMeasure': 'ml/cm^2', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Liver Parenchyma Transaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).'}, {'id': 'OG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)'}], 'classes': [{'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '305'}, {'value': '100', 'groupId': 'OG001', 'lowerLimit': '20', 'upperLimit': '300'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'Duration of liver parenchyma transaction (min)', 'unitOfMeasure': 'min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Necessity to Apply the Pringle Maneuver.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}, {'id': 'OG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'the number of participants who needed to apply the Pringle maneuver', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Total Duration of Pringle Maneuver.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}, {'id': 'OG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '59'}, {'value': '18', 'groupId': 'OG001', 'lowerLimit': '2', 'upperLimit': '48'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '1 day', 'description': 'The total duration of Pringle maneuver (min)', 'unitOfMeasure': 'min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Stay (Day)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}, {'id': 'OG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '5', 'upperLimit': '16'}, {'value': '8', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '19'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 month', 'description': 'Hospital stay (day)', 'unitOfMeasure': 'day', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Morbidity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}, {'id': 'OG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 days', '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.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).'}, {'id': 'FG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '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', 'preAssignmentDetails': 'Of 68 enrolled participants, met inlusion criteria and were randomized.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}, {'id': 'BG001', 'title': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)\n\nliver transection during laparoscopic liver resection: liver transection during laparoscopic liver resection'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '56', 'spread': '14', 'groupId': 'BG000'}, {'value': '54', 'spread': '15', 'groupId': 'BG001'}, {'value': '55', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Body mass index (BMI)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.4', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '30', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '29', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Physical status classification system (ASA)', 'classes': [{'title': 'ASA 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'ASA 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'ASA 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': '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.', 'unitOfMeasure': 'Participants'}, {'title': 'Malignant/benign lesions', 'classes': [{'title': 'Malignant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}]}, {'title': 'Bening', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tumor size (mm)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '211'}, {'value': '51', 'groupId': 'BG001', 'lowerLimit': '16', 'upperLimit': '165'}, {'value': '61', 'groupId': 'BG002', 'lowerLimit': '16', 'upperLimit': '211'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mm', 'dispersionType': 'FULL_RANGE'}, {'title': 'Postero-superior segments', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Difficulty index score (IWATE Criteria) Low\\Intermediate\\Advanced\\Expert', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '7', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '12'}, {'value': '7', 'groupId': 'BG002', 'lowerLimit': '2', 'upperLimit': '12'}]}]}], 'paramType': 'MEDIAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-20', 'size': 658095, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-02T08:27', 'hasProtocol': True}, {'date': '2017-02-20', 'size': 402850, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-06-02T08:28', 'hasProtocol': False}, {'date': '2020-05-15', 'size': 427031, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-04T08:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two groups will be compared. Group 1: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).\n\nGroup 2: liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-02', 'studyFirstSubmitDate': '2017-06-26', 'resultsFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2017-07-03', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-02', 'studyFirstPostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Morbidity', 'timeFrame': '30 days', '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.'}], 'primaryOutcomes': [{'measure': 'Intraoperative Blood Loss', 'timeFrame': '1 day', '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.'}], 'secondaryOutcomes': [{'measure': 'Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)', 'timeFrame': '1 day', 'description': 'Аbsolute measurement of blood loss in relation to resection size (ml/cm\\^2).'}, {'measure': 'Duration of Liver Parenchyma Transaction', 'timeFrame': '1 day', 'description': 'Duration of liver parenchyma transaction (min)'}, {'measure': 'Necessity to Apply the Pringle Maneuver.', 'timeFrame': '1 day', 'description': 'the number of participants who needed to apply the Pringle maneuver'}, {'measure': 'The Total Duration of Pringle Maneuver.', 'timeFrame': '1 day', 'description': 'The total duration of Pringle maneuver (min)'}, {'measure': 'Hospital Stay (Day)', 'timeFrame': 'up to 1 month', 'description': 'Hospital stay (day)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal liver metastases', 'hepatocellular carcinoma', 'intrahepatic cholangiocellular carcinoma', 'tumor of liver', 'focal nodular hyperplasia liver', 'hemangioma liver'], 'conditions': ['Liver Transection During Laparoscopic Liver Resection']}, 'descriptionModule': {'briefSummary': 'Background: until now, there is no agreement about the safest and feasible method for liver parenchyma transection during laparoscopic liver resection.\n\nStudy 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Gender: both, male and female\n* Minimum age 18 years\n* Maximum age: 80 years\n* ASA physical status I-IV\n* BMI up to 40 kg/m2\n* No simultaneous extrahepatic intra-abdominal procedures (bile duct resection, colon resection, partial duodenum resection)\n* Total bilirubin up to 100mmol/l if jaundice presents in non-cirrhotic patients\n* If cirrhosis is present, class A and B according to CTP score\n\nExclusion Criteria:\n\n* • Difficulty index \\> 12 points (see below)\n\n * Tumor invasion of IVC or portal trunk (necessity of vascular reconstruction)\n * Repeated liver resection before laparoscopic resection (the single resection before is not a contraindication)\n * Simultaneous extra-hepatic intra-abdominal procedures (bile duct resection, colon resection etc.)\n * Age under 18 years\n * Age above 80 years\n * ASA physical status \\>IV\n * BMI \\> 40 kg/m2\n * Total bilirubin \\>100mmol/l if jaundice presents in non-cirrhotic patients\n * If cirrhosis is present, class C according to CTP score\n * Persons who are incapable of giving consent\n * Pregnant or breast-feeding women\n * Patients enlisted in other studies'}, 'identificationModule': {'nctId': 'NCT03208192', 'acronym': 'LLS', 'briefTitle': 'Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection', 'organization': {'class': 'OTHER', 'fullName': 'Moscow Clinical Scientific Center'}, 'officialTitle': 'Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection', 'orgStudyIdInfo': {'id': 'MCNC 01/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ErbeJet', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon) and water-jet dissector (ERBEJET 2).', 'interventionNames': ['Procedure: liver transection during laparoscopic liver resection']}, {'type': 'EXPERIMENTAL', 'label': 'Misonix', 'description': 'liver resection using a bipolar dissector (Erbe), ultracision harmonic scalpel (Ethicon), and ultrasonic aspirator (Misonix/SonaStar Ultrasonic Surgical Aspiration System)', 'interventionNames': ['Procedure: liver transection during laparoscopic liver resection']}], 'interventions': [{'name': 'liver transection during laparoscopic liver resection', 'type': 'PROCEDURE', 'description': 'liver transection during laparoscopic liver resection', 'armGroupLabels': ['ErbeJet', 'Misonix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '111123', 'city': 'Moscow', 'state': 'Entuziastov Shosse,86', 'country': 'Russia', 'facility': 'Moscow Clinical scientific Center', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Mikhail Efanov, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Moscow Clinical Scientific Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moscow Clinical Scientific Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinial Research', 'investigatorFullName': 'Ivan Kazakov', 'investigatorAffiliation': 'Moscow Clinical Scientific Center'}}}}