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Completed

NCT Number: NCT02041065

Waterjet Versus Ultrasound Dissection During Hepatic Transection

Before liver transection patients are allocated to either waterjet or CUSA to divide the liver parenchyma.

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Key information

Conditions

Liver Tumour Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Karolinska University Hospital, Centra of Gastroenterology

Stockholm, 14186, Sweden

About this study

Transection time, bloodloss, total operation time and postoperative complication rates are registered.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hepatic tumour suitable for resection
  • patients 18 year or older Segmental resection Local resection Left sided hemihepatectomy

Exclusion criteria

  • Right sided hemihepatectoyReresection In Situ Split Liver Extended left- and rightsided hemihepatectomy Lobus caudatus resection Central resections Hilus tumour/Klatskin/Cholangiocarcinoma Surgery on biliary tree Extended resection on other organs

Resection on gallbladder Resection on other organs during the same operation.

Treatment and study plan

Waterjet induced dissection

Device

Waterjet induced dissection of the liver during resection.Waterjet dissection device mechanically separates hepatic tissue from bile ducts and vessels, the latter two to be separately ligated.

CUSA induced dissection

Device

Ultrasound based destruction of the liver

Primary outcomes

  1. Peroperative bloodloss

    Time frame: During liver transection (on an average<90 min)

    Peroperative bloodloss in ml during liver transection by use of either waterjet or CUSA.

Secondary outcomes

  1. Transection time in minutes

    Time frame: During liver transection (on an average< 90 minutes)

  2. Operation time in minutes

    Time frame: Time spent in theater in minutes (on an average <240 minutes)

  3. Hospital stay in days

    Time frame: Days spent in hospital after surgery (on an average < 10 days)

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Bengt Isaksson
  • Jansson, Anders, M.D.

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Jan 20, 2014
Registry last updated
Sep 1, 2015

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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