N/A
N=68
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
Liver Transection During Laparoscopic Liver Resection
Bottom Line
View on ClinicalTrials.gov: NCT03208192 ↗Enrolled (actual)
68
Serious AEs
5.9%
Results posted
Sep 2020
Primary outcome: Primary: Intraoperative Blood Loss — 195; 218 ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- liver transection during laparoscopic liver resection (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Moscow Clinical Scientific Center
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraoperative Blood Loss |
195; 218 | — |
| SECONDARY Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2) |
3.9; 5 | — |
| SECONDARY Duration of Liver Parenchyma Transaction |
107; 100 | — |
| SECONDARY Necessity to Apply the Pringle Maneuver. |
15; 21 | — |
| SECONDARY The Total Duration of Pringle Maneuver. |
23; 18 | — |
| SECONDARY Hospital Stay (Day) |
8; 8 | — |
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
Data sourced from ClinicalTrials.gov (NCT03208192). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.