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Completed

NCT Number: NCT04052633

Success of Intraoperative Cholangiography

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.

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Key information

Conditions

Cholecystolithiasis Bile Duct Diseases Biliary Tract Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases Gallbladder Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Finland Central Hospital

Jyväskylä, 40620, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all consecutive cholecystectomy patients during January 2018 to August 2018

Exclusion criteria

  • none

Treatment and study plan

intraoperative cholangiography

Radiation

success or failure of cholangiography

Primary outcomes

  1. number of intraoperative cholangiography

    Time frame: 6 months

    number of successful cannulation

Secondary outcomes

  1. technical success of intraoperative cholangiography

    Time frame: 6 months

    grades of technical success ( easy, , minimal difficulties, major difficulties)

Sponsors and collaborators

Lead sponsor

Jyväskylä Central Hospital

Other

Registry information

Official study title

Success of Routine Intraoperative Cholangiography

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 12, 2019
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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