Calcular Obstructive JaundiceNCT07084493
*Effect of Prophylactic CBD Stenting Versus Non Stenting on Recurrence of CBD Stones in Patients Awaiting Cholecystectomy*
A study testing CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent and biliary stent in people with Calcular Obstructive Jaundice, run by Assiut University at 1 site in Egypt.
Trial summary
Primary objective: Compare recurrence rates of CBD stones in stented versus non-stented patients. Secondary objectives: Identify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Calcular Obstructive Jaundice
- What is being tested?
- CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent and biliary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
"Inclusion Criteria":
- Age > 18 years.
- Documented CBD stones by various imaging or ERCP.
- Successful biliary clearance by ERCP.
- Scheduled for elective cholecystectomy within 3 months.
- Provide written informed consent.
"Exclusion Criteria":
- Previous biliary surgery.
- Known malignancy involving the biliary system.
- Comorbid conditions preventing surgery such as bleeding tendency.
- Pregnancy.
- Failure to obtain consent.
- Failed stone clearance.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Huda Mokhtar Huda Mokhtar, Assistant lecturer, master degree contact
Egypt1 site
Assiut university
Asyut, 71511
Assiut university assiut university, 01154664323, hudamokhtar2571994@aun.edu.eg
About this study
Official title: *Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*
Primary objective:
Compare recurrence rates of CBD stones in stented versus non-stented patients.
Secondary objectives:
Identify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Explore impact on quality of life and ease of subsequent cholecystectomy.
Read the detailed description
Choledocholithiasis, the presence of stones in the common bile duct (CBD), occurs in 10-20% of patients with symptomatic gallstones and can lead to severe complications such as obstructive jaundice, cholangitis, and pancreatitis Endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction is the gold standard treatment, achieving >90% success rates in ductal clearance.
Despite successful initial clearance, CBD stone recurrence remains a significant issue, with reported rates ranging from 4% to 24% .
To reduce recurrence, prophylactic biliary stenting has been proposed, particularly in high-risk patients (e.g., large or multiple stones, dilated CBD, periampullary diverticulum) However, its routine use remains controversial due to conflicting evidence on efficacy, stent-related complications (e.g., migration, occlusion, cholangitis), and increased healthcare costs.
- Conditions
- Calcular Obstructive Jaundice
- Being tested
- CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent, biliary stent
- Keywords
- CBD stones, ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stentDevice
prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent
biliary stentDevice
prophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent
| Study group | Role | What they receive |
|---|---|---|
| CASE WITH cbd STONES | Active comparator | Age > 18 years.
Documented CBD stones by various imaging or ERCP.
Successful biliary clearance by ERCP.
Scheduled for elective cholecystectomy within 3 months.
Provide written informed consent. Receives: Device: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent; Device: biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calcular Obstructive JaundiceStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Following ERCP and biliary duct clearance, participants will be randomly assigned in a 1:1 ratio to either: Stent Group: Placement of a prophylactic CBD stent will be placed. Control Group: No stent placement after biliary clearance. Patients will be monitored every month until cholecystectomy or up to 3 months, whichever comes first. Follow-up includes: Clinical assessment. LFTs and pancreatic enzymes. Imaging: US (MRCP if symptomatic). Stent removal (if placed) at 3 months or earlier if symptomatic. Repeat ERCP for recurrence.
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Mokhtar Salim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084493
- Sponsor's protocol ID
- ERCP in CBD stones
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: SPSS version 22 will be used. Continuous variables: mean ± SD or median (IQR), compared via t-test or Mann-Whitney. Categorical variables: chi-square or Fisher's exact test. Kaplan-Meier for time-to-event outcomes. Multivariate regression to identify predictors. P \< 0.05 considered significant.
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- *Effect of Prophylactic Common Bile Duct Stenting Versus Non Stenting on Recurrence of Common Bile Duct Stones in Patients Awaiting Cholecystectomy*
- ClinicalTrials.gov ID
- NCT07084493
- Acronym / sponsor ID
- ERCP in CBD stones
- Conditions
- Calcular Obstructive Jaundice
- Keywords
- CBD stones, ERCP
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Jul 2025 (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.
Primary objective:
Compare recurrence rates of CBD stones in stented versus non-stented patients.
Secondary objectives:
Identify predictors of stone recurrence. Assess the incidence and risk factors for post-ERCP complications. Evaluate time to recurrence and rate of hospital readmissions. Explore impact on quality of life and ease of subsequent cholecystectomy.
Detailed description
Choledocholithiasis, the presence of stones in the common bile duct (CBD), occurs in 10-20% of patients with symptomatic gallstones and can lead to severe complications such as obstructive jaundice, cholangitis, and pancreatitis Endoscopic retrograde cholangiopancreatography (ERCP) with stone extraction is the gold standard treatment, achieving >90% success rates in ductal clearance.
Despite successful initial clearance, CBD stone recurrence remains a significant issue, with reported rates ranging from 4% to 24% .
To reduce recurrence, prophylactic biliary stenting has been proposed, particularly in high-risk patients (e.g., large or multiple stones, dilated CBD, periampullary diverticulum) However, its routine use remains controversial due to conflicting evidence on efficacy, stent-related complications (e.g., migration, occlusion, cholangitis), and increased healthcare costs.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Following ERCP and biliary duct clearance, participants will be randomly assigned in a 1:1 ratio to either: Stent Group: Placement of a prophylactic CBD stent will be placed. Control Group: No stent placement after biliary clearance. Patients will be monitored every month until cholecystectomy or up to 3 months, whichever comes first. Follow-up includes: Clinical assessment. LFTs and pancreatic enzymes. Imaging: US (MRCP if symptomatic). Stent removal (if placed) at 3 months or earlier if symptomatic. Repeat ERCP for recurrence.
| Arm | Type | Receives |
|---|---|---|
| CASE WITH cbd STONES | Active comparator | Device: CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent, Device: biliary stentAge > 18 years. Documented CBD stones by various imaging or ERCP. Successful biliary clearance by ERCP. Scheduled for elective cholecystectomy within 3 months. Provide written informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stentprophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent | Device | CASE WITH cbd STONES |
| biliary stentprophylactic CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm double-pigtail stent | Device | CASE WITH cbd STONES |
Primary outcome
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
Time frame: 3 months
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. SPSS version 22 will be used. Continuous variables: mean ± SD or median (IQR), compared via t-test or Mann-Whitney. Categorical variables: chi-square or Fisher's exact test. Kaplan-Meier for time-to-event outcomes. Multivariate regression to identify predictors. P < 0.05 considered significant.
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.
Huda Mokhtar Huda Mokhtar, Assistant lecturer, master degree contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBD stent either a 7-Fr and 7 cm or a 10-Fr and 7-cm OR double-pigtail stent and biliary stent in people with Calcular Obstructive Jaundice, 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?
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: opening soon, as of the sponsor's last update on 7 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huda Mokhtar Huda Mokhtar, Assistant lecturer, master degree (0201154664323, hudamokhtar2571994@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of CBD stones within 3 months, confirmed by imaging or ERCP. (time frame: 3 months). 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 7 Aug 2025.