CholedocholithiasisNCT04690101
Treatment of Choledocolithiasis by Laparoscopic Exploration
An observational study of Choledocholithiasis, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado.
Trial summary
There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis
- What is being tested?
- none, this is an observational study
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2009to 30 Nov 2020
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service of the General Ignacio Zaragoza
Who may be able to join
- Patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service
Who cannot join
- Less than 18 year old
About this study
Official title: Treatment of Choledocolithiasis by Laparoscopic Exploration of The Bile Tract After Failed Endoscopic Cholangiopancreatography
There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct. A retrospective, descriptive, observational study was taken of patients with a diagnosis of cholecystocholedocholithiasis that failed ERCP and who underwent laparoscopic cholecystectomy with exploration of the bile duct.
Read the detailed description
this study was revision of clinical files.
- Conditions
- Choledocholithiasis
- Being tested
- none, this is an observational study
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
none, this is an observational studyOther
none, this is an observational study
What is being measured
The primary outcome is the main question the study is designed to answer.
TREATMENT OF CHOLEDOCOLITHIASIS
TREATMENT OF CHOLEDOCOLITHIASIS AFTER FAILED ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY
Measured: 2009-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start31 Jan 2009
- Primary completion1 Dec 2018
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholedocholithiasisStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Israel De Alba Cruz, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690101
- Sponsor's protocol ID
- IDC001
- Status last verified
- Dec 2020
- First submitted
- 22 Dec 2020
- Last updated
- 30 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Choledocolithiasis by Laparoscopic Exploration of The Bile Tract After Failed Endoscopic Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT04690101
- Acronym / sponsor ID
- IDC001
- Conditions
- Choledocholithiasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Instituto de Seguridad y Servicios Sociales de los Trabajadores del EstadoOther government
- Study start
- 31 Jan 2009 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 30 Dec 2020 (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.
There are three treatment options for choledocholithiasis: endoscopic retrograde cholangiopancreatography (ERCP) followed by laparoscopic cholecystectomy; laparoscopic exploration of the main bile duct with concomitant cholecystectomy; and open cholecystectomy with exploration of the main bile duct. A retrospective, descriptive, observational study was taken of patients with a diagnosis of cholecystocholedocholithiasis that failed ERCP and who underwent laparoscopic cholecystectomy with exploration of the bile duct.
Detailed description
this study was revision of clinical files.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service of the General Ignacio Zaragoza
Key inclusion criteria (1 listed)
- Patients with a diagnosis of cholecyto-choledocholithiasis with failed ERCP and who were taken to LCDE in the General Surgery service
Key exclusion criteria (1 listed)
- Less than 18 year old
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 |
|---|---|---|
| none, this is an observational studynone, this is an observational study | Other | – |
Primary outcome
TREATMENT OF CHOLEDOCOLITHIASIS
Time frame: 2009-2018
TREATMENT OF CHOLEDOCOLITHIASIS AFTER FAILED ENDOSCOPIC CHOLANGIOPANCREATOGRAPHY
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 30 Dec 2020.
- Individual participant dataSharing planned: Undecided
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ChOlecystectomy aFter successFul Endoscopic Common Bile Duct Stone Extraction in Elderly
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Prophylactic PS Placement to Prevent Pancreatitis After Endoscopic Transpapillary GPC for Cholelithiasis With Concomitant Choledocholithiasis
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis, run by Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado.
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 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
TREATMENT OF CHOLEDOCOLITHIASIS (time frame: 2009-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2020.