NCT03817723

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2019

Completed
Last Updated

January 25, 2019

Status Verified

January 1, 2019

Enrollment Period

2 years

First QC Date

January 23, 2019

Last Update Submit

January 23, 2019

Conditions

Radiation Exposure

Keywords

Radiation dosecholangiographyCholecystectomy

Outcome Measures

Primary Outcomes (1)

  • mean kerma area product (KAP)

    KAP values were measured using inbuilt ionization chambers in c-arms.

    2 years

Secondary Outcomes (1)

  • mean fluoroscopy time (FT )

    2 years

Study Arms (2)

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

Interventions

c-arm cholangiographyRADIATION
Resident surgeonSpecialist surgeon

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Finland Central Hospital

Jyväskylä, 40620, Finland

Location

Related Publications (17)

  • 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.

    PMID: 22183717BACKGROUND

  • 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.

    PMID: 7693932BACKGROUND

  • Tusek D, Hufschmidt M, Raguse T. [Value of intraoperative laparoscopic cholangiography]. Zentralbl Chir. 1997;122(3):153-6. German.

    PMID: 9206908BACKGROUND

  • 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.

    PMID: 8441966BACKGROUND

  • 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.

    PMID: 9410677BACKGROUND

  • 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.

    PMID: 15943720BACKGROUND

  • 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.

    PMID: 21254008BACKGROUND

  • 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.

    PMID: 22732420BACKGROUND

  • 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.

    PMID: 30069810BACKGROUND

  • 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.

    PMID: 19118424BACKGROUND

  • 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.

    PMID: 20706739BACKGROUND

  • 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.

    PMID: 29603004BACKGROUND

  • 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.

    PMID: 25133326BACKGROUND

  • 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.

    PMID: 18398646BACKGROUND

  • 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.

    PMID: 27844236BACKGROUND

  • Jolley J, Lomelin D, Simorov A, Tadaki C, Oleynikov D. Resident involvement in laparoscopic procedures does not worsen clinical outcomes but may increase operative times and length of hospital stay. Surg Endosc. 2016 Sep;30(9):3783-91. doi: 10.1007/s00464-015-4674-z. Epub 2015 Nov 19.

    PMID: 26585194BACKGROUND

  • Buddingh KT, Weersma RK, Savenije RA, van Dam GM, Nieuwenhuijs VB. Lower rate of major bile duct injury and increased intraoperative management of common bile duct stones after implementation of routine intraoperative cholangiography. J Am Coll Surg. 2011 Aug;213(2):267-74. doi: 10.1016/j.jamcollsurg.2011.03.004. Epub 2011 Apr 3.

    PMID: 21459631RESULT

Study Officials

  • Anne Mattila, M.D., Ph.D.

    consultant surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, Ph.D.

Study Record Dates

First Submitted

January 23, 2019

First Posted

January 25, 2019

Study Start

January 1, 2016

Primary Completion

December 31, 2017

Study Completion

September 1, 2018

Last Updated

January 25, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)