Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03817723
Other study ID # Rad1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2016
Est. completion date September 1, 2018

Study information

Verified date January 2019
Source Jyväskylä Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. In this study we included 324 intraoperative cholangiographies performed with c-arm equipment not exceeding 10 years of age.


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.


Recruitment information / eligibility

Status Completed
Enrollment 324
Est. completion date September 1, 2018
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Radiation:
c-arm cholangiography


Locations

Country Name City State
Finland Central Finland Central Hospital Jyväskylä

Sponsors (1)

Lead Sponsor Collaborator
Jyväskylä Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (17)

Amott D, Webb A, Tulloh B. Prospective comparison of routine and selective operative cholangiography. ANZ J Surg. 2005 Jun;75(6):378-82. — View Citation

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 — View Citation

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. Review. — View Citation

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. Erratum in: Eur Radiol. 2018 Aug 30;:. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Möller 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. — View Citation

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. — View Citation

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. German. — View Citation

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. — View Citation

Rehani MM, Ciraj-Bjelac O, Vañó 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. Erratum in: Ann ICRP. 2016 Dec;45(3-4):351. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

* Note: There are 17 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary mean kerma area product (KAP) KAP values were measured using inbuilt ionization chambers in c-arms. 2 years
Secondary mean fluoroscopy time (FT ) recorded from c -arms 2 years
See also
  Status Clinical Trial Phase
Completed NCT03649451 - Reference Dose Levels During Fluoroscopically Guided Procedures in Operating Rooms
Completed NCT03305978 - Pulmonary Nodule Detection: Comparison of an Ultra Low Dose vs Standard Scan. N/A
Recruiting NCT04139096 - Genetic Susceptibility to Radiation Induced Thyroid Cancer
Completed NCT01430975 - Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning at Two Clinical Sites N/A
Completed NCT01424774 - Prospective Evaluation of Strontium in Patients After CardioGen-82 PET MPI Scanning N/A
Completed NCT00378053 - A Prospective Study of Radiation Exposure to Surgeons N/A
Recruiting NCT05561439 - Individual Dosimetric Monitoring of Workers During Interventional Radiology and Cardiology Procedures for Cardiologists and Radiologists in France
Completed NCT04078165 - Suspended Personal Protection System Versus Conventional Protection (Aka Zero-Gravity vs Shield and Apron) N/A
Recruiting NCT04694391 - Genomic Study of Relapse Esophageal Cancer After Radiotherapy
Not yet recruiting NCT04403815 - Radiation Exposure During Coronary Procedures According to Vascular Access
Recruiting NCT04285944 - Operator Radiation Protection During Cardiac Catheterization Using Mavig X-ray Protective Drapes®. N/A
Completed NCT04363190 - Genomic Instability in Vascular Surgeons
Completed NCT04404257 - Reduce Radiation Exposure in Fluoroscopic Interventions Evaluation N/A
Recruiting NCT04678258 - Zero Fluoroscopy Voltage Guided vs. Linear CTI Ablation N/A
Recruiting NCT03386500 - Safety Study of BMX-001 (Radio-protector) in Patients With Newly Diagnosed Anal Cancer Phase 1/Phase 2
Recruiting NCT05833516 - Hyper Adduction of Right Radial Artery/Arm vs Left Drag Over Technique
Recruiting NCT03946280 - Utility of 3D Navigation to Reduce Ionizing Radiation in Common Flutter Ablation. Study of Personnel and Patient Dosimetry N/A
Completed NCT03985488 - Radiation Exposure Assessment in Fluoroscopy
Completed NCT03605030 - Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures N/A
Recruiting NCT02689908 - Individualized Radiation Dose Control N/A