NCT04052633

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

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, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
Last Updated

August 12, 2019

Status Verified

August 1, 2019

Enrollment Period

1.2 years

First QC Date

March 30, 2019

Last Update Submit

August 7, 2019

Conditions

CholecystolithiasisCholedocholithiasis

Keywords

c arm cholangiographycholecystectomy

Outcome Measures

Primary Outcomes (1)

  • number of intraoperative cholangiography

    number of successful cannulation

    6 months

Secondary Outcomes (1)

  • technical success of intraoperative cholangiography

    6 months

Study Arms (2)

Cholangiography success

From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative success of cholangiography

Radiation: intraoperative cholangiography

Cholangiography failure

From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative failure of cholangiography

Radiation: intraoperative cholangiography

Interventions

intraoperative cholangiographyRADIATION

success or failure of cholangiography

Cholangiography failureCholangiography success

Eligibility Criteria

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

You may qualify if:

  • all consecutive cholecystectomy patients during January 2018 to August 2018

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Finland Central Hospital

Jyväskylä, 40620, Finland

Location

Related Publications (7)

  • 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.

    PMID: 18392894BACKGROUND

  • 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.

    PMID: 17285384BACKGROUND

  • 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

  • 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

  • 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

  • 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

  • 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.

    PMID: 29953458RESULT

MeSH Terms

Conditions

CholecystolithiasisCholedocholithiasis

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder DiseasesCommon Bile Duct DiseasesBile Duct Diseases

Study Officials

  • Anne Mattila, M.D., Ph.D.

    consultant surgeon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2019

First Posted

August 12, 2019

Study Start

January 1, 2018

Primary Completion

March 26, 2019

Study Completion

March 26, 2019

Last Updated

August 12, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)