Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Lap… (NCT03208192) | Clinical Trial Compass
CompletedNot Applicable
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
Russia68 participantsStarted 2017-02-20
Plain-language 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
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…