Clinical trial NCT04052633: Success of Intraoperative Cholangiography
Official title: Success of Routine Intraoperative Cholangiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholecystolithiasis
Choledocholithiasis
Keywords: c arm cholangiography
cholecystectomy
Lead sponsor: Jyväskylä Central Hospital
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 201
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all consecutive cholecystectomy patients during January 2018 to August 2018 which are operated with open or laparoscopic cholecystectomy for symptomatic cholelithiasis

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* all consecutive cholecystectomy patients during January 2018 to August 2018

Exclusion Criteria:

* none

Primary outcomes:
measure: number of intraoperative cholangiography
timeFrame: 6 months
Secondary outcomes:
measure: technical success of intraoperative cholangiography
timeFrame: 6 months
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Finland Central Hospital
Study officials:
affiliation: consultant surgeon
name: Anne Mattila, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1007/s00464-006-9127-2. Epub 2007 Feb 7.
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.
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.
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.
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. No abstract available.
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/journal.pone.0199147. eCollection 2018.