Biliary StonesNCT04308993
Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease
An observational study of Biliary Stones, run by Imam Abdulrahman Bin Faisal University.
Trial summary
Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stones
- What is being tested?
- percutaneous transhepatic choledochoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1999to 19 Aug 2019
- 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: Most patients were elderly (median age, 60 years). The male-to-female ratio was higher than the norm for biliary stones (1:1.4). The most common reasons for failure of conventional endoscopic retrograde cholangiopancreatography (ERCP) were high American Society of Anesthesia (ASA) score (8 patients 53%), technical failure of ERCP (4 patients, 27%), previous Roux-en-Y gastric bypass (two patients, 13%), and post-common bile duct (CBD) injury with T-tube insertion (one patient, 7%). The stone sites were the CBD, gallbladder, and intrahepatic bile duct in nine (60%), three (20%), and three (20%) patients, respectively
Who may be able to join
- complete records
Who cannot join
- lost follow up
About this study
Official title: Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study
Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones.
Methods:
Fifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.
Read the detailed description
The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively.
Urological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.
- Conditions
- Biliary Stones
- Being tested
- percutaneous transhepatic choledochoscopy
- Medical subject headings
- Cholecystolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous transhepatic choledochoscopyProcedure or surgery
Also called extracorporeal shock wave lithotripsy (ESWL)
percutaneous transhepatic choledochoscopy
What is being measured
The primary outcome is the main question the study is designed to answer.
symptoms
success rate of biliary stone clearance or asymptomatic derbies
Measured: at least one year follow up
Secondary outcomes (1)
ultrasound
evidence of stone clearance
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Jan 1999
- Primary completion31 Aug 2016
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StonesStudies 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
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanan Mesfer Alghamdi, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04308993
- Sponsor's protocol ID
- IAU-PEBE
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study
- ClinicalTrials.gov ID
- NCT04308993
- Acronym / sponsor ID
- IAU-PEBE
- Conditions
- Biliary Stones
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Study start
- 1 Jan 1999 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 16 Mar 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.
Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones.
Methods:
Fifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.
Detailed description
The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively.
Urological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Most patients were elderly (median age, 60 years). The male-to-female ratio was higher than the norm for biliary stones (1:1.4). The most common reasons for failure of conventional endoscopic retrograde cholangiopancreatography (ERCP) were high American Society of Anesthesia (ASA) score (8 patients 53%), technical failure of ERCP (4 patients, 27%), previous Roux-en-Y gastric bypass (two patients, 13%), and post-common bile duct (CBD) injury with T-tube insertion (one patient, 7%). The stone sites were the CBD, gallbladder, and intrahepatic bile duct in nine (60%), three (20%), and three (20%) patients, respectively
Key inclusion criteria (1 listed)
- complete records
Key exclusion criteria (1 listed)
- lost follow up
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 |
|---|---|---|
| percutaneous transhepatic choledochoscopyAlso: extracorporeal shock wave lithotripsy (ESWL)percutaneous transhepatic choledochoscopy | Procedure or surgery | – |
Primary outcome
symptoms
Time frame: at least one year follow up
success rate of biliary stone clearance or asymptomatic derbies
1 secondary outcome
ultrasound
Time frame: one month
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 16 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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 Biliary Stones, run by Imam Abdulrahman Bin Faisal University.
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 16 Mar 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?
symptoms (time frame: at least one year follow up). 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 16 Mar 2020; AzTrials last refreshed its copy on 27 Oct 2026.