Radiation Exposure in Intraoperative Cholangiography

January 23, 2019 updated by: Olli Helminen, Jyväskylä Central Hospital

Radiation Exposure of Intraoperative Cholangiography During Cholecystectomy

Aims: to determine the radiation exposure of routine intraoperative cholangiography (IOC )during cholecystectomy and examine the factors affecting radiation dose and fluoroscopy time (FT).

Methods: 598 intraoperative cholangiography examinations were performed at the Central Finland Central Hospital. In this study we included 324 intraoperative cholangiographies performed with c-arm equipment not exceeding 10 years of age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

From January 2016 to December 2017, consecutive 598 intraoperative cholangiography examinations were performed at the Central Finland Central Hospital. In this study we included 353 cholangiographies, that were performed with our c-arm equipment not exceeding 10 years of age in the beginning of 2016. The main measures of outcome were the recorded radiation dose data of c-arm systems from our manual database .

Another 25 cases were excluded because it was not possible to cross-check the manually recorded radiation dose data from the Picture Archiving and Communication System (PACS ). Additional 4 patients who underwent intraoperative endoscopic retrograde cholangiopancreatography (ERCP) were removed from the radiation exposure analysis because IOC and ERCP were performed consequently with the same c-arm and the radiation exposure of IOC could not be separated from the registered total KAP and FT. Thus the final analysis consisted of 324 IOCs. KAP (Kerma area product) is the product of air Kerma in the center of the imaging area multiplied with size of the imaging area. For simplicity we have unified varying units received from different c-arms and will only use Gray multiplied by square centimeters (Gycm2 ). KAP values were measured using inbuilt ionization chambers in c-arms. For this study we collected the KAP values from exposure and pulsed fluoroscopy. We also recorded the fluoroscopy time (s).

Laparoscopic cholecystectomies were performed both by residents and specialist surgeons.

Ethics: No ethical approval or written informed consent were needed because the study was retrospective in nature. The study was approved by the hospital administration.

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Jyväskylä, Finland, 40620
        • Central Finland Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent laparoscopic , open or conversion cholecystectomy with intraoperative cholangiography

Description

Inclusion Criteria:

  • Consecutive intraoperative cholangiographies performed with c-arm equipment not exceeding 10 years of age between January 2016 to December 2017

Exclusion Criteria:

  • intraoperative cholangiographies performed with c-arm equipment exceeding over 10 years of age between January 2016 to December 2017
  • patients who underwent intraoperative endoscopic retrograde cholangiopancreatography (ERCP)
  • if the manually recorded radiation dose data could not be cross-checked from the Picture Archiving and Communication System ( PACS ) system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Specialist surgeon
Radiation exposure of intraoperative cholangiography during cholecystectomy. C-arm cholangiography is performed routinely. KAP (Kerma area product) is the product of air Kerma in the center of the imaging area multiplied with size of the imaging area. For simplicity we have unified varying units received from different c-arms and will only use Gray multiplied by square centimeters (Gycm2 ). KAP values were measured using inbuilt ionization chambers in c-arms. For this study we collected the KAP values from exposure and pulsed fluoroscopy. We also recorded the fluoroscopy time (s).
Resident surgeon
Radiation exposure of intraoperative cholangiography during cholecystectomy.C-arm cholangiography is performed routinely. KAP (Kerma area product) is the product of air Kerma in the center of the imaging area multiplied with size of the imaging area. For simplicity we have unified varying units received from different c-arms and will only use Gray multiplied by square centimeters (Gycm2 ). KAP values were measured using inbuilt ionization chambers in c-arms. For this study we collected the KAP values from exposure and pulsed fluoroscopy. We also recorded the fluoroscopy time (s).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean kerma area product (KAP)
Time Frame: 2 years
KAP values were measured using inbuilt ionization chambers in c-arms.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean fluoroscopy time (FT )
Time Frame: 2 years
recorded from c -arms
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Anne Mattila, M.D., Ph.D., consultant surgeon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 23, 2019

First Submitted That Met QC Criteria

January 23, 2019

First Posted (Actual)

January 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 25, 2019

Last Update Submitted That Met QC Criteria

January 23, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Rad1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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