Clinical trial · Observational
Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors
Biliary or Digestive Protection by Room Air Interposition for Thermal Ablation of Central Hepatic Tumors With High Iatrogenic Risk
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ablation Techniques | — | UNRESOLVED | — |
| Carcinoma, Hepatocellular (RENI) | Carcinoma | ONTOLOGY_EXACT | 0.85 |
| Liver Neoplasm | Liver Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Microwaves | — | UNRESOLVED | — |
| Neoplasm Metastasis | — | UNRESOLVED | — |
| Radiofrequency Ablation | — | UNRESOLVED | — |
| Radiology, Interventional | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thermal Ablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients
- description
- Patients with single liver tumor traited by thermoablation with high iatrogenic risk, with biliary or digestive protection by ambiant air interposition
- interventionNames
- Procedure: Thermal Ablation
Primary outcomes (4)
- measure
- Feasability
- timeFrame
- 1 day
- description
- Technical succes of the procedure = feasibility of insulation with room air
- measure
- Security
- timeFrame
- 2 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available