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OpenTrials
Completed

NCT Number: NCT05495529

Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors

This study aims to analyse retrospectively the feasibility, the safety, and the efficiency, of biliary or digestive protection with room air interposition for thermal ablation of central liver tumors with high iatrogenic risk.

Thermal ablation is a mini-invasive and curative treatement of liver tumors. However, it requires to be carefull about surrunding organs, such as digestive structures or central biliary tree, which can be injured if not insulated.

The technique of gas interposition to protect adjacent gut is already known and validated with carbonic gas. Nevertheless, resorption of this gas is very fast, making its use tricky to keep a correct insulation during the whole thermal ablation process.

Room air interposition is easy to use and can offer a slow resorption speed. Furthermore no datas are available concerning the use of room air whatever the organ protected, and the protection of central biliary tree whatever the gas used.

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Key information

Conditions

Radiology, Interventional Ablation Techniques Carcinoma Carcinoma, Hepatocellular (RENI) Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasm Liver Neoplasms Microwaves Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Radiofrequency Ablation

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with single malignant primary or secondary liver tumor
  • Thermal ablation area located within 1 centimeter from central biliary tree or gut
  • Thermal insulation using room air interposition
  • Follow-up of at least 2 months

Treatment and study plan

Thermal ablation

Procedure

Data collection about complications, succes of the procedure, succes of complete treatement, recurrence, biologic pertubations.

Primary outcomes

  1. Feasability

    Time frame: 1 day

    Technical succes of the procedure = feasibility of insulation with room air

  2. Security

    Time frame: 2 months

    Complications (intraoperative clinical or radiological event/abnormality, biological perturbation, clinical event in hospitalization report, imaging request), classified according to SIR (Society of Interventional Radiology) classification in two classes: minor (no additional therapy needed) and major (specific therapy needed) complications.

  3. Efficacity

    Time frame: 2 months

    Response in imaging (MRI or CT) for the tumor treated with thermal ablation

  4. Clinical success

    Time frame: 2 months

    Overall survival

Secondary outcomes

  1. Local and distant recurrence

    Time frame: 2 months

    • Local recurrence: defined by MRI or CT recurrence within 10 mm from thermal ablation area
    • Distant recurrence:

    I. Hepatic: defined by MRI or CT intra-hepatic recurrence which is not defined as local recurrence II. Extrahepatic: defined by MRI or CT extra-hepatic recurrence

  2. Local tumorous recurrence free survival

    Time frame: 2 months

    Local tumorous recurrence free survival analysis

  3. Progression free survival

    Time frame: 2 months

    Local or distant recurrence free survival analysis

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk

Important dates

Study start
2013
Primary completion
2021
Study completion
2022
First posted
Aug 10, 2022
Registry last updated
Aug 10, 2022

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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