Clinical trial NCT03208192: Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
Official title: Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Moscow Clinical Scientific Center
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Intraoperative Blood Loss
timeFrame: 1 day
Secondary outcomes:
measure: Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)
timeFrame: 1 day
measure: Duration of Liver Parenchyma Transaction
timeFrame: 1 day
measure: Necessity to Apply the Pringle Maneuver.
timeFrame: 1 day
measure: The Total Duration of Pringle Maneuver.
timeFrame: 1 day
measure: Hospital Stay (Day)
timeFrame: up to 1 month
Other outcomes:
measure: Morbidity
timeFrame: 30 days
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Clinical scientific Center
state: Entuziastov Shosse,86
Study officials:
affiliation: Moscow Clinical Scientific Center
name: Mikhail Efanov, MD, PhD
role: STUDY_CHAIR
References: