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NCT04052633 Clinical Trial

Success of Intraoperative Cholangiography

Choledocholithiasis Clinical Trial

Official title:
Success of Routine Intraoperative Cholangiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04052633
Other study ID # IOC1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date March 26, 2019

Study information
Verified date August 2019
Source Jyväskylä Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of the present study was to evaluate the success of routine use of intraoperative cholangiography (IOC ) and to examine the factors that are hindering the performance of intraoperative c-arm cholangiography.

Description:

From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed were entered in a prospective database. IOC has been instructed to be performed routinely when feasible during cholecystectomy since 1998. All elective operations were performed either by residents or specialist surgeons. For this study the investigators collected the radiation exposure values from exposure and pulsed fluoroscopy. Fluoroscopy time (s) was recorded.The operating surgeon was asked to fulfill a questionnaire directly after the cholecystectomy. The technical success and reasons for possible deferral of IOC were documented.Patient data from unsuccessful or deferred cholangiography cases was checked 6 months after cholecystectomy for possible symptomatic residual choledocholithiasis.Laparoscopic cholecystectomies were performed both by residents and specialist surgeons.

Ethics: The study was approved by the hospital administration.

Recruitment information / eligibility
Status Completed
Enrollment 201
Est. completion date March 26, 2019
Est. primary completion date March 26, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- all consecutive cholecystectomy patients during January 2018 to August 2018

Exclusion Criteria:

- none

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• intraoperative cholangiography
success or failure of 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 (7)

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

Hamouda AH, Goh W, Mahmud S, Khan M, Nassar AH. Intraoperative cholangiography facilitates simple transcystic clearance of ductal stones in units without expertise for laparoscopic bile duct surgery. Surg Endosc. 2007 Jun;21(6):955-9. Epub 2007 Feb 7. — View Citation

Iranmanesh P, Tobler O, De Sousa S, Andres A, Frossard JL, Morel P, Toso C. Feasibility, benefit and risk of systematic intraoperative cholangiogram in patients undergoing emergency cholecystectomy. PLoS One. 2018 Jun 28;13(6):e0199147. doi: 10.1371/journ — 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

Nassar AH, El Shallaly G, Hamouda AH. Optimising laparoscopic cholangiography time using a simple cannulation technique. Surg Endosc. 2009 Mar;23(3):513-7. doi: 10.1007/s00464-008-9853-8. Epub 2008 Apr 4. — 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

Outcome
Type Measure Description Time frame Safety issue
Primary number of intraoperative cholangiography number of successful cannulation 6 months
Secondary technical success of intraoperative cholangiography grades of technical success ( easy, , minimal difficulties, major difficulties) 6 months
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