CholecystolithiasisNCT04052633
Success of Intraoperative Cholangiography
An observational study of Cholecystolithiasis and Choledocholithiasis, run by Jyväskylä Central Hospital at 1 site in Finland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholecystolithiasis, Choledocholithiasis
- What is being tested?
- intraoperative cholangiography
- Type of treatment
- Surgery or procedure
- How many people
- 201 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2018to 26 Mar 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all consecutive cholecystectomy patients during January 2018 to August 2018 which are operated with open or laparoscopic cholecystectomy for symptomatic cholelithiasis
Who may be able to join
- all consecutive cholecystectomy patients during January 2018 to August 2018
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Success of Routine 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.
Read the 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.
- Conditions
- Cholecystolithiasis, Choledocholithiasis
- Being tested
- intraoperative cholangiography
- Keywords
- c arm cholangiography, cholecystectomy
- Medical subject headings
- Cholecystolithiasis, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative cholangiographyRadiation
success or failure of cholangiography
| Study group | Role | What they receive |
|---|---|---|
| Cholangiography success | From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative success of cholangiography Receives: Radiation: intraoperative cholangiography | |
| Cholangiography failure | From January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative failure of cholangiography Receives: Radiation: intraoperative cholangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of intraoperative cholangiography
number of successful cannulation
Measured: 6 months
Secondary outcomes (1)
technical success of intraoperative cholangiography
grades of technical success ( easy, , minimal difficulties, major difficulties)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start1 Jan 2018
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CholecystolithiasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Jyväskylä Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olli Helminen, Jyväskylä Central Hospital
- Investigators
- Anne Mattila, M.D., Ph.D., Principal investigator, consultant surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052633
- Sponsor's protocol ID
- IOC1
- Status last verified
- Aug 2019
- First submitted
- 30 Mar 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18392894Hamouda 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.
PubMed 17285384Karthikesalingam 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.
PubMed 19118424Jolley 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.
PubMed 26585194Ford 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.
PubMed 22183717Overby 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.
PubMed 20706739Iranmanesh 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.
PubMed 29953458
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Success of Routine Intraoperative Cholangiography
- ClinicalTrials.gov ID
- NCT04052633
- Acronym / sponsor ID
- IOC1
- Conditions
- Cholecystolithiasis, Choledocholithiasis
- Keywords
- c arm cholangiography, cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Jyväskylä Central HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 12 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholangiography success | – | Radiation: intraoperative cholangiographyFrom January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative success of cholangiography |
| Cholangiography failure | – | Radiation: intraoperative cholangiographyFrom January 2018 to August 2018 all consecutive elective and emergency cholecystectomies performed with intraoperative failure of cholangiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all consecutive cholecystectomy patients during January 2018 to August 2018 which are operated with open or laparoscopic cholecystectomy for symptomatic cholelithiasis
Key inclusion criteria (1 listed)
- all consecutive cholecystectomy patients during January 2018 to August 2018
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative cholangiographysuccess or failure of cholangiography | Radiation | Cholangiography failure, Cholangiography success |
Primary outcome
number of intraoperative cholangiography
Time frame: 6 months
number of successful cannulation
1 secondary outcome
technical success of intraoperative cholangiography
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Background: PubMed 18392894Nassar 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.
- Background: PubMed 17285384Hamouda 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.
- Background: PubMed 19118424Karthikesalingam 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.
- Background: PubMed 26585194Jolley 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.
- Background: PubMed 22183717Ford 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.
- Background: PubMed 20706739Overby 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.
- Results publication: PubMed 29953458Iranmanesh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Mattila, M.D., Ph.D. principal investigator
consultant surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystolithiasis and Choledocholithiasis, run by Jyväskylä Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of intraoperative cholangiography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04052633, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2019.