Common Bile Duct CalculiNCT05746832
Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference
A study testing Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) in people with Common Bile Duct Calculi, run by Assiut University at 1 site in Egypt.
Trial summary
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or… Read more about this study
- Who is it for?
- Ages 15 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Bile Duct Calculi
- What is being tested?
- Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2024to Dec 2024
- Phase
- Interventional
- 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 15 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All cases of difficult common bile duct stones leading to variable occlusion.
- Patients fit for intervention.
- Patients informed consent for study.
Who cannot join
- Surgically unfit cases according to ASA
- Locally advanced irresectable cases.
- Patients refuse consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference Versus Follow up on Stent.
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Read the detailed description
Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.
- Conditions
- Common Bile Duct Calculi
- Being tested
- Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)Procedure or surgery
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
| Study group | Role | What they receive |
|---|---|---|
| One session application of (ERCP) in the management of common bile duct stones. | Active comparator | One session application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery. Receives: Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) |
| Two sessions application of (ERCP) in the management of common bile duct stones. | Active comparator | Two sessions application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones.and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery. Receives: Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of procedure.
This is measured in hours.
Measured: On the day of determined procedure.
Rate of stone size reduction.
This is measured in millimeters.
Measured: Baseline.
Width of CBD.
This is measured in millimeters.
Measured: Baseline.
Degree of stone clearance and complications.
Those are determined by close monitoring of patients whether after ERCP or surgery.
Measured: Baseline.
Postoperative morbidity and mortality.
Those are measures in percentage of patients in the study.
Measured: Baseline.
Secondary outcomes (5)
Blood loss during the procedure.
This is measured in milliliters.
Measured: Baseline.
Postoperative wound infection.
This is measured in percentage of patients in the study.
Measured: Baseline.
Postoperative hospital stay.
This is measured in days.
Measured: Baseline.
Postoperative hemorrhage.
This is measured in milliliters.
Measured: Baseline.
Postoperative 30 day mortality rate.
This is measured in percentage of patients in the study.
Measured: Baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study startSep 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Bile Duct CalculiStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zyad Osama Harith, Assiut University
- Investigators
- Hisham Ali Ryad, Prof., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746832
- Sponsor's protocol ID
- CBD stones managment by ERCP
- Status last verified
- Jan 2024
- First submitted
- 1 Nov 2021
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failed Retrograde Cholangiopancreatography (ERCP) Stone Extraction: Surgical Interference Versus Follow up on Stent.
- ClinicalTrials.gov ID
- NCT05746832
- Acronym / sponsor ID
- CBD stones managment by ERCP
- Conditions
- Common Bile Duct Calculi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Feb 2023 (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.
Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery.
Detailed description
Gallstones are a very common problem in developed countries. Most patients with gallstones remain asymptomatic throughout their lifetime, but 10 % - 25 % of them may develop biliary pain or complications, with an annual risk of about 2 % - 3 % for symptomatic disease and 1 % - 2 % for major complications. The development of symptomatic disease and complications is mostly related to the migration of stones into the common bile duct (CBD). Common bile duct stones (CBDSs) may be treated by endoscopic retrograde cholangiopancreatography (ERCP) or surgically during cholecystectomy. Removal of common bile duct (CBD) stones can still be difficult in patients with large or multiple stones despite an adequate sphincterotomy. Procedures such as mechanical, extracorporeal, electrohydraulic or laser lithotripsy, and chemical dissolution have been introduced as effective therapeutic interventions for irretrievable CBD stones. However, these techniques have their drawbacks, are not widely available, or are still under clinical evaluation. Several studies have shown that insertion of an endoscopic biliary stent is a safe, effective, and widely available measure. An indwelling stent provides biliary drainage and fragments large stones, thereby reducing the risk of cholangitis and allowing stones to pass spontaneously or rendering them more extractable at a later procedure. Thus, this study intends to shed a light on advances in diagnosis and management in patients with biliary difficult stones.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One session application of (ERCP) in the management of common bile duct stones. | Active comparator | Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)One session application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery. |
| Two sessions application of (ERCP) in the management of common bile duct stones. | Active comparator | Procedure: Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)Two sessions application of endoscopic stenting retrograde cholangiopancreatography (ERCP) in the management and clearance of difficult common bile duct stones.and assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery. |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- All cases of difficult common bile duct stones leading to variable occlusion.
- Patients fit for intervention.
- Patients informed consent for study.
Key exclusion criteria (3 listed)
- Surgically unfit cases according to ASA
- Locally advanced irresectable cases.
- Patients refuse consent to participate in the study.
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 |
|---|---|---|
| Endoscopic stenting Retrograde Cholangiopancreatography (ERCP)Assessment of the differences in stone size and the largest CBD diameter before and after stenting in one or two sessions. Stone clearance and complications were also determined with the ERCP, and factors associated with complete clearance were evaluated in patients with difficult CBD stones (a large [≥ 20 mm] or multiple [≥ 3 sized ≥ 15 mm] CBD stones). And also compared the outcomes with conventional procedure of open surgery. | Procedure or surgery | One session application of (ERCP) in the management of common bile duct stones., Two sessions application of (ERCP) in the management of common bile duct stones. |
Primary outcome
Time of procedure.
Time frame: On the day of determined procedure.
This is measured in hours.
Rate of stone size reduction.
Time frame: Baseline.
This is measured in millimeters.
Width of CBD.
Time frame: Baseline.
This is measured in millimeters.
Degree of stone clearance and complications.
Time frame: Baseline.
Those are determined by close monitoring of patients whether after ERCP or surgery.
Postoperative morbidity and mortality.
Time frame: Baseline.
Those are measures in percentage of patients in the study.
5 secondary outcomes
Blood loss during the procedure.
Time frame: Baseline.
Postoperative wound infection.
Time frame: Baseline.
Postoperative hospital stay.
Time frame: Baseline.
Postoperative hemorrhage.
Time frame: Baseline.
Postoperative 30 day mortality rate.
Time frame: Baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
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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.
Hisham Ali Ryad, Prof. principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic stenting Retrograde Cholangiopancreatography (ERCP) in people with Common Bile Duct Calculi, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Jan 2024. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zyad Osama Harith, resident (01149863511, zyadosama200000@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of procedure. (time frame: On the day of determined procedure.). The study lists 5 primary outcomes in all. 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 31 Jan 2024.