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

Sponsored by Moscow Clinical Scientific Center

About this trial

Last updated 5 years ago

Study ID

MCNC 01/2017

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 80 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 5 years ago

What is this trial about?

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

What are the participation requirements?

Yes

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

No

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