Liver Transection During Laparoscopic Liver Resection Clinical Trial
— LLSOfficial title:
Comparison of Hydro-dissection Versus Ultrasonic Aspirator in Division of Liver Parenchyma in Laparoscopic Resection
| Verified date | September 2020 |
| Source | Moscow Clinical Scientific Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 68 |
| Est. completion date | May 20, 2020 |
| Est. primary completion date | May 20, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Moscow Clinical scientific Center | Moscow | Entuziastov Shosse,86 |
| Lead Sponsor | Collaborator |
|---|---|
| Moscow Clinical Scientific Center |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Morbidity | 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. | 30 days | |
| Primary | Intraoperative Blood Loss | 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. | 1 day | |
| Secondary | ?bsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2) | ?bsolute measurement of blood loss in relation to resection size (ml/cm^2). | 1 day | |
| Secondary | Duration of Liver Parenchyma Transaction | Duration of liver parenchyma transaction (min) | 1 day | |
| Secondary | Necessity to Apply the Pringle Maneuver. | the number of participants who needed to apply the Pringle maneuver | 1 day | |
| Secondary | The Total Duration of Pringle Maneuver. | The total duration of Pringle maneuver (min) | 1 day | |
| Secondary | Hospital Stay (Day) | Hospital stay (day) | up to 1 month |