CholedocholithiasisNCT02461147
Prospective Validation of "Cholecystectomy First" Strategy for Gallstone Migration
An observational study of Choledocholithiasis and Gallstone Migration, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Choledocholithiasis, Gallstone Migration, Cholecystitis
- What is being tested?
- Cholecystectomy with intraoperative cholangiogram
- Type of treatment
- Surgery or procedure
- How many people
- 161 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2013to Jun 2016
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients admitted through the emergency department for an acute gallstone-related condition.
Who may be able to join
- Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis)
Who cannot join
- Severe sepsis or septic shock
- contra-indication to surgery
- previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.)
- previous cholecystectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the same investigators team. The aim of this study is to prospectively analyze the outcomes of this strategy.
Read the detailed description
A previous randomized controlled trial comparing initial cholecystectomy with intraoperative cholangiogram (IOC) versus common bile duct (CBD) assessment and subsequent cholecystectomy for patients admitted in the emergency room with an acute gallstone-related condition and with an intermediate risk of common bile duct stone was performed by the investigators. This study had been registered on Clinicaltrials.gov as well and had shown that a strategy with initial cholecystectomy significantly decreased the length of hospital stay and the number of CBD investigations procedures.
Initial cholecystectomy with IOC is now the standard management strategy for these patients in the investigators hospital. The goal of this study is to perform a prospective validation of this strategy and to analyze if the results obtained in the previously mentioned randomized controlled trial are confirmed on a larger patients cohort. This study will be observational, since the intervention (initial cholecystectomy) is not assigned by the investigators, but is already a standard treatment strategy at our institution.
- Conditions
- Choledocholithiasis, Gallstone Migration, Cholecystitis, Gallstone Pancreatitis, Cholangitis
- Being tested
- Cholecystectomy with intraoperative cholangiogram
- Medical subject headings
- Choledocholithiasis, Cholecystitis, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecystectomy with intraoperative cholangiogramProcedure or surgery
cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.
| Study group | Role | What they receive |
|---|---|---|
| Validation cohort | All patients of the study (single group, single arm) will undergo initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, according to the standard protocol of treatment previously implemented at the investigators institution. Receives: Procedure: Cholecystectomy with intraoperative cholangiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay [days]
Measured: 1-100 days
Secondary outcomes (3)
Number of common bile duct investigations [N]
These include number of endoscopic ultrasounds (EUS), magnetic cholangio-pancreatography (MRCP) and endoscopic retrograde cholangio-pancreatography (ERCP) performed during the patient's hospital stay
Measured: Anytime during hospital stay, an expected average of 7 days
Common bile duct clearance rate [%]
Percentage of patients where common bile duct (CBD) clearance was achieved after ERCP (did not require surgical exploration because of ERCP failure)
Measured: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
Morbidity
Morbidity will be assessed for each patient according to the Dindo-Clavien classification of surgical complications, including death.
Measured: From admission up to 6 months after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startSep 2013
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pouya Iranmanesh, University Hospital, Geneva
- Investigators
- Pouya Iranmanesh, MD, Principal investigator, Geneva University Hospital, Division of Digestive SurgeryChristian Toso, MD-PhD, Study director, Geneva University Hospital, Division of Digestive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461147
- Sponsor's protocol ID
- CCK first validation
- Status last verified
- Nov 2020
- First submitted
- 19 Jan 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Iranmanesh P, Frossard JL, Mugnier-Konrad B, Morel P, Majno P, Nguyen-Tang T, Berney T, Mentha G, Toso C. Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial. JAMA. 2014 Jul;312(2):137-44. doi: 10.1001/jama.2014.7587.
PubMed 25005650Iranmanesh P, Frossard JL, Toso C. Treatment for patients at intermediate risk of a common duct stone--reply. JAMA. 2014 Nov 19;312(19):2043-4. doi: 10.1001/jama.2014.13425. No abstract available.
PubMed 25399287Iranmanesh P, Frossard JL, Toso C. Reply: To PMID 25451658. Gastroenterology. 2015 Jan;148(1):252. doi: 10.1053/j.gastro.2014.11.016. Epub 2014 Nov 21. No abstract available.
PubMed 25451659
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Cholecystectomy With Intraoperative Cholangiography for Patients at Intermediate Risk of Common Bile Duct Stone Migration : Prospective Validation and Analysis
- ClinicalTrials.gov ID
- NCT02461147
- Acronym / sponsor ID
- CCK first validation
- Conditions
- Choledocholithiasis, Gallstone Migration, Cholecystitis, Gallstone Pancreatitis, Cholangitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Jun 2015 (estimated)
- 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.
Initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the same investigators team. The aim of this study is to prospectively analyze the outcomes of this strategy.
Detailed description
A previous randomized controlled trial comparing initial cholecystectomy with intraoperative cholangiogram (IOC) versus common bile duct (CBD) assessment and subsequent cholecystectomy for patients admitted in the emergency room with an acute gallstone-related condition and with an intermediate risk of common bile duct stone was performed by the investigators. This study had been registered on Clinicaltrials.gov as well and had shown that a strategy with initial cholecystectomy significantly decreased the length of hospital stay and the number of CBD investigations procedures.
Initial cholecystectomy with IOC is now the standard management strategy for these patients in the investigators hospital. The goal of this study is to perform a prospective validation of this strategy and to analyze if the results obtained in the previously mentioned randomized controlled trial are confirmed on a larger patients cohort. This study will be observational, since the intervention (initial cholecystectomy) is not assigned by the investigators, but is already a standard treatment strategy at our institution.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Validation cohort | – | Procedure: Cholecystectomy with intraoperative cholangiogramAll patients of the study (single group, single arm) will undergo initial cholecystectomy with intraoperative cholangiogram, followed if required by ERCP, according to the standard protocol of treatment previously implemented at the investigators institution. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients admitted through the emergency department for an acute gallstone-related condition.
Key inclusion criteria (1 listed)
- Admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis)
Key exclusion criteria (4 listed)
- Severe sepsis or septic shock
- contra-indication to surgery
- previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.)
- previous cholecystectomy
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 |
|---|---|---|
| Cholecystectomy with intraoperative cholangiogramcf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution. | Procedure or surgery | Validation cohort |
Primary outcome
Length of hospital stay [days]
Time frame: 1-100 days
3 secondary outcomes
Number of common bile duct investigations [N]
Time frame: Anytime during hospital stay, an expected average of 7 days
Common bile duct clearance rate [%]
Time frame: This outcome will be assessed after each ERCP performed during hospital stay, an expected average of 7 days
Morbidity
Time frame: From admission up to 6 months after hospital discharge
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 4 Nov 2020.
- Results publication: PubMed 25005650Iranmanesh P, Frossard JL, Mugnier-Konrad B, Morel P, Majno P, Nguyen-Tang T, Berney T, Mentha G, Toso C. Initial cholecystectomy vs sequential common duct endoscopic assessment and subsequent cholecystectomy for suspected gallstone migration: a randomized clinical trial. JAMA. 2014 Jul;312(2):137-44. doi: 10.1001/jama.2014.7587.
- Results publication: PubMed 25399287Iranmanesh P, Frossard JL, Toso C. Treatment for patients at intermediate risk of a common duct stone--reply. JAMA. 2014 Nov 19;312(19):2043-4. doi: 10.1001/jama.2014.13425. No abstract available.
- Results publication: PubMed 25451659Iranmanesh P, Frossard JL, Toso C. Reply: To PMID 25451658. Gastroenterology. 2015 Jan;148(1):252. doi: 10.1053/j.gastro.2014.11.016. Epub 2014 Nov 21. No abstract available.
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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.
Pouya Iranmanesh, MD principal investigator
Geneva University Hospital, Division of Digestive Surgery
Christian Toso, MD-PhD study director
Geneva University Hospital, Division of Digestive Surgery
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 Choledocholithiasis and Gallstone Migration, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 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 4 Nov 2020. 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 Switzerland. 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?
Length of hospital stay [days] (time frame: 1-100 days). 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 NCT02461147, which also lists 3 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 4 Nov 2020.