Impact of New Interventional Imaging Modality Use on Patient Radiation Exposure in Transarterial Chemoembolization

NCT03698643 | Completed

• 1 other identifier: RECHMPL18_0136
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

Transarterial chemoembolization (TACE) is the most performed endovascular interventional radiology (IR) procedure. TACE procedures are performed in an IR suite, most of which are equipped with floor-based flat-panel robotic C-arm allowing two-dimensional imaging. Cone-beam computed tomography (CBCT) has been developed to allow three-dimensional navigation but has several limitations such as reduced signal to noise ratio and small field-of-view, and seems to have negative impact on patient radiation exposure. Another option to perform 3D imaging is called angio-CT which combines a CT-scan and a floor-based flat-panel robotic C-arm in a single IR suite. Even if some publications have shown benefit of angio-CT in TACE procedures in Japan, no study about angio-CT in liver IR procedures has been conducted in the occidental world so far. The purpose of our study was to assess the impact of angio-CT use on patient radiation exposure and treatment quality in TACE procedures compared to CBCT. This before-after study consisted of a review of consecutive TACE procedures performed between January 2016 and September 2017 in our institution with two different imaging modalities, defining two study groups (C-arm with CBCT versus angio-CT).

Conditions

Hepatic Tumor

Outcome Measures

Primary Outcomes (1)

• Patient effective radiation dose per TACE

  Patient effective radiation dose (mSv) per TACE : Dose-area product (in mGy/cm\^2) and dose-length product (in mGy/cm) will be combined and converted to report effective dose (in mSv).

  1 day

Secondary Outcomes (6)

• Air kerma per TACE

  1 day

• Fluoroscopy time per TACE

  1 day

• Number of CBCT acquisitions per TACE

  1 day

• Number of CT acquisitions per TACE

  1 day

• Treatment targeting

  1 day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

TACE sessions performed on adult patients with primary or secondary liver tumor(s) after multidisciplinary tumor meeting approval

You may qualify if:

• Age \> or = 18 years
• primary or secondary liver tumor(s)
• TACE approved by multidisciplinary tumor meeting

You may not qualify if:

• \- TACE not performed

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• BORIS GUIU, PU-PH

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 9, 2018
• Study Start: April 1, 2018
• Primary Completion: April 30, 2018
• Study Completion: May 1, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-09

Locations

FR (1)