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Radiation Exposure in Intraoperative Cholangiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817723
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Olli Helminen, Jyväskylä Central Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment
Radiation Exposure Radiation: c-arm cholangiography

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 Design
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Study Type : Observational
Actual Enrollment : 324 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Radiation Exposure of Intraoperative Cholangiography During Cholecystectomy
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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).
 Radiation: c-arm cholangiography
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).
 Radiation: c-arm cholangiography


Outcome Measures
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Primary Outcome Measures :
  1. mean kerma area product (KAP) [ Time Frame: 2 years ]
    KAP values were measured using inbuilt ionization chambers in c-arms.


Secondary Outcome Measures :
  1. mean fluoroscopy time (FT ) [ Time Frame: 2 years ]
    recorded from c -arms


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who underwent laparoscopic , open or conversion cholecystectomy with intraoperative cholangiography
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817723


Locations
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Finland
Central Finland Central Hospital
Jyväskylä, Finland, 40620
Sponsors and Collaborators
Jyväskylä Central Hospital
Investigators
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Principal Investigator: Anne Mattila, M.D., Ph.D. consultant surgeon
  Study Documents (Full-Text)

Documents provided by Olli Helminen, Jyväskylä Central Hospital:
Statistical Analysis Plan  [PDF] October 1, 2018

More Information
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Publications of Results:

Other Publications:

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Responsible Party: Olli Helminen, M.D, Ph.D., Jyväskylä Central Hospital
ClinicalTrials.gov Identifier: NCT03817723    
Other Study ID Numbers: Rad1
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Olli Helminen, Jyväskylä Central Hospital:
Radiation dose
cholangiography
Cholecystectomy