Radiation ExposureNCT03817723

Radiation Exposure in Intraoperative Cholangiography

An observational study of Radiation Exposure, run by Jyväskylä Central Hospital at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Radiation Exposure
What is being tested?: c-arm cholangiography
Type of treatment: Surgery or procedure
How many people: 324 participants
Where: 1 siteFinland
Study dates: 1 Jan 2016to 1 Sep 2018
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Finland1 site

Central Finland Central Hospital
Jyväskylä, 40620

Other trials in Finland

About this study

Official title: 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.

Read the 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.

Conditions: Radiation Exposure
Being tested: c-arm cholangiography
Keywords: Radiation dose, cholangiography, Cholecystectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

c-arm cholangiographyRadiation

Study groups in NCT03817723
Study group	Role	What they receive
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). Receives: 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). Receives: Radiation: c-arm cholangiography

What is being measured

The primary outcome is the main question the study is designed to answer.

mean kerma area product (KAP)
KAP values were measured using inbuilt ionization chambers in c-arms.
Measured: 2 years

Secondary outcomes (1)

mean fluoroscopy time (FT )
recorded from c -arms
Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20161 Sep 2018

First posted25 Jan 2019
Study start1 Jan 2016
Primary completion31 Dec 2017
Study completion1 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Radiation ExposureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 324 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03817723
Sponsor's protocol ID: Rad1
Status last verified: Jan 2019
First submitted: 23 Jan 2019
Last updated: 25 Jan 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ford JA, Soop M, Du J, Loveday BP, Rodgers M. Systematic review of intraoperative cholangiography in cholecystectomy. Br J Surg. 2012 Feb;99(2):160-7. doi: 10.1002/bjs.7809. Epub 2011 Dec 19.
PubMed 22183717
Murison MS, Gartell PC, McGinn FP. Does selective peroperative cholangiography result in missed common bile duct stones? J R Coll Surg Edinb. 1993 Aug;38(4):220-4.
PubMed 7693932
Tusek D, Hufschmidt M, Raguse T. [Value of intraoperative laparoscopic cholangiography]. Zentralbl Chir. 1997;122(3):153-6. German.
PubMed 9206908
Hauer-Jensen M, Karesen R, Nygaard K, Solheim K, Amlie EJ, Havig O, Rosseland AR. Prospective randomized study of routine intraoperative cholangiography during open cholecystectomy: long-term follow-up and multivariate analysis of predictors of choledocholithiasis. Surgery. 1993 Mar;113(3):318-23.
PubMed 8441966
Nies C, Bauknecht F, Groth C, Clerici T, Bartsch D, Lange J, Rothmund M. [Intraoperative cholangiography as a routine method? A prospective, controlled, randomized study]. Chirurg. 1997 Sep;68(9):892-7. doi: 10.1007/s001040050290. German.
PubMed 9410677
Amott D, Webb A, Tulloh B. Prospective comparison of routine and selective operative cholangiography. ANZ J Surg. 2005 Jun;75(6):378-82. doi: 10.1111/j.1445-2197.2005.03393.x.
PubMed 15943720
Khan OA, Balaji S, Branagan G, Bennett DH, Davies N. Randomized clinical trial of routine on-table cholangiography during laparoscopic cholecystectomy. Br J Surg. 2011 Mar;98(3):362-7. doi: 10.1002/bjs.7356. Epub 2010 Nov 24.
PubMed 21254008
Rehani MM, Ciraj-Bjelac O, Vano E, Miller DL, Walsh S, Giordano BD, Persliden J. ICRP Publication 117. Radiological protection in fluoroscopically guided procedures performed outside the imaging department. Ann ICRP. 2010 Dec;40(6):1-102. doi: 10.1016/j.icrp.2012.03.001.
PubMed 22732420
Greffier J, Etard C, Mares O, Pereira F, Defez D, Duverger C, Branchereau P, Beregi JP, Coulomb R, Larbi A. Patient dose reference levels in surgery: a multicenter study. Eur Radiol. 2019 Feb;29(2):674-681. doi: 10.1007/s00330-018-5600-2. Epub 2018 Aug 1.
PubMed 30069810
Karthikesalingam A, Markar SR, Weerakkody R, Walsh SR, Carroll N, Praseedom RK. Radiation exposure during laparoscopic cholecystectomy with routine intraoperative cholangiography. Surg Endosc. 2009 Aug;23(8):1845-8. doi: 10.1007/s00464-008-0279-0. Epub 2009 Jan 1.
PubMed 19118424
Overby DW, Apelgren KN, Richardson W, Fanelli R; Society of American Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc. 2010 Oct;24(10):2368-86. doi: 10.1007/s00464-010-1268-7. Epub 2010 Aug 13. No abstract available.
PubMed 20706739
Singh AN, Kilambi R. Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with gallbladder stones with common bile duct stones: systematic review and meta-analysis of randomized trials with trial sequential analysis. Surg Endosc. 2018 Sep;32(9):3763-3776. doi: 10.1007/s00464-018-6170-8. Epub 2018 Mar 30.
PubMed 29603004
Moller M, Gustafsson U, Rasmussen F, Persson G, Thorell A. Natural course vs interventions to clear common bile duct stones: data from the Swedish Registry for Gallstone Surgery and Endoscopic Retrograde Cholangiopancreatography (GallRiks). JAMA Surg. 2014 Oct;149(10):1008-13. doi: 10.1001/jamasurg.2014.249.
PubMed 25133326
Videhult P, Sandblom G, Rasmussen IC. How reliable is intraoperative cholangiography as a method for detecting common bile duct stones? : A prospective population-based study on 1171 patients. Surg Endosc. 2009 Feb;23(2):304-12. doi: 10.1007/s00464-008-9883-2. Epub 2008 Apr 9.
PubMed 18398646
Vlek SL, van Dam DA, Rubinstein SM, de Lange-de Klerk ESM, Schoonmade LJ, Tuynman JB, Meijerink WJHJ, Ankersmit M. Biliary tract visualization using near-infrared imaging with indocyanine green during laparoscopic cholecystectomy: results of a systematic review. Surg Endosc. 2017 Jul;31(7):2731-2742. doi: 10.1007/s00464-016-5318-7. Epub 2016 Nov 14.
PubMed 27844236

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Radiation Exposure of Intraoperative Cholangiography During Cholecystectomy
ClinicalTrials.gov ID: NCT03817723
Acronym / sponsor ID: Rad1
Conditions: Radiation Exposure
Keywords: Radiation dose, cholangiography, Cholecystectomy
Study type: Observational
Recruitment status: Completed
Enrolment: 324 participants (actual)
Lead sponsor: Jyväskylä Central HospitalUniversity, hospital or other
Study start: 1 Jan 2016 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 1 Sep 2018 (actual)
First posted: 25 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Specialist surgeon	–	Radiation: c-arm cholangiographyRadiation 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: c-arm cholangiographyRadiation 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).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Patients who underwent laparoscopic , open or conversion cholecystectomy with intraoperative cholangiography

Key inclusion criteria (1 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
c-arm cholangiography	Radiation	Resident surgeon, Specialist surgeon

Primary outcome

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

1 secondary outcome

mean fluoroscopy time (FT )
Time frame: 2 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
Background: PubMed 22183717Ford JA, Soop M, Du J, Loveday BP, Rodgers M. Systematic review of intraoperative cholangiography in cholecystectomy. Br J Surg. 2012 Feb;99(2):160-7. doi: 10.1002/bjs.7809. Epub 2011 Dec 19.
Background: PubMed 7693932Murison MS, Gartell PC, McGinn FP. Does selective peroperative cholangiography result in missed common bile duct stones? J R Coll Surg Edinb. 1993 Aug;38(4):220-4.
Background: PubMed 9206908Tusek D, Hufschmidt M, Raguse T. [Value of intraoperative laparoscopic cholangiography]. Zentralbl Chir. 1997;122(3):153-6. German.
Background: PubMed 8441966Hauer-Jensen M, Karesen R, Nygaard K, Solheim K, Amlie EJ, Havig O, Rosseland AR. Prospective randomized study of routine intraoperative cholangiography during open cholecystectomy: long-term follow-up and multivariate analysis of predictors of choledocholithiasis. Surgery. 1993 Mar;113(3):318-23.
Background: PubMed 9410677Nies C, Bauknecht F, Groth C, Clerici T, Bartsch D, Lange J, Rothmund M. [Intraoperative cholangiography as a routine method? A prospective, controlled, randomized study]. Chirurg. 1997 Sep;68(9):892-7. doi: 10.1007/s001040050290. German.
Background: PubMed 15943720Amott D, Webb A, Tulloh B. Prospective comparison of routine and selective operative cholangiography. ANZ J Surg. 2005 Jun;75(6):378-82. doi: 10.1111/j.1445-2197.2005.03393.x.
Background: PubMed 21254008Khan OA, Balaji S, Branagan G, Bennett DH, Davies N. Randomized clinical trial of routine on-table cholangiography during laparoscopic cholecystectomy. Br J Surg. 2011 Mar;98(3):362-7. doi: 10.1002/bjs.7356. Epub 2010 Nov 24.
Background: PubMed 22732420Rehani MM, Ciraj-Bjelac O, Vano E, Miller DL, Walsh S, Giordano BD, Persliden J. ICRP Publication 117. Radiological protection in fluoroscopically guided procedures performed outside the imaging department. Ann ICRP. 2010 Dec;40(6):1-102. doi: 10.1016/j.icrp.2012.03.001.
Background: PubMed 30069810Greffier J, Etard C, Mares O, Pereira F, Defez D, Duverger C, Branchereau P, Beregi JP, Coulomb R, Larbi A. Patient dose reference levels in surgery: a multicenter study. Eur Radiol. 2019 Feb;29(2):674-681. doi: 10.1007/s00330-018-5600-2. Epub 2018 Aug 1.
Background: PubMed 19118424Karthikesalingam A, Markar SR, Weerakkody R, Walsh SR, Carroll N, Praseedom RK. Radiation exposure during laparoscopic cholecystectomy with routine intraoperative cholangiography. Surg Endosc. 2009 Aug;23(8):1845-8. doi: 10.1007/s00464-008-0279-0. Epub 2009 Jan 1.
Background: PubMed 20706739Overby DW, Apelgren KN, Richardson W, Fanelli R; Society of American Gastrointestinal and Endoscopic Surgeons. SAGES guidelines for the clinical application of laparoscopic biliary tract surgery. Surg Endosc. 2010 Oct;24(10):2368-86. doi: 10.1007/s00464-010-1268-7. Epub 2010 Aug 13. No abstract available.
Background: PubMed 29603004Singh AN, Kilambi R. Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with gallbladder stones with common bile duct stones: systematic review and meta-analysis of randomized trials with trial sequential analysis. Surg Endosc. 2018 Sep;32(9):3763-3776. doi: 10.1007/s00464-018-6170-8. Epub 2018 Mar 30.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anne Mattila, M.D., Ph.D. principal investigator

consultant surgeon

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Radiation Exposure, run by Jyväskylä Central Hospital at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

mean kerma area product (KAP) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03817723, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.