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OpenTrials
Completed

NCT Number: NCT03208192

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

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moscow Clinical scientific Center

Moscow, Entuziastov Shosse,86, 111123, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liver transection during laparoscopic liver resection

Procedure

liver transection during laparoscopic liver resection

Primary outcomes

  1. Intraoperative Blood Loss

    Time frame: 1 day

    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.

Secondary outcomes

  1. Аbsolute Measurement of Blood Loss in Relation to Resection Size (ml/cm^2)

    Time frame: 1 day

    Аbsolute measurement of blood loss in relation to resection size (ml/cm^2).

  2. Duration of Liver Parenchyma Transaction

    Time frame: 1 day

    Duration of liver parenchyma transaction (min)

  3. Necessity to Apply the Pringle Maneuver.

    Time frame: 1 day

    the number of participants who needed to apply the Pringle maneuver

  4. The Total Duration of Pringle Maneuver.

    Time frame: 1 day

    The total duration of Pringle maneuver (min)

  5. Hospital Stay (Day)

    Time frame: up to 1 month

    Hospital stay (day)

Other outcomes

  1. Morbidity

    Time frame: 30 days

    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.

Sponsors and collaborators

Lead sponsor

Moscow Clinical Scientific Center

Other

Registry information

Acronym: LLS

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2017
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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