CholedocholithiasisNCT06265311
IDUS in CBD Stone Recurrence High Risk Patients
A study testing IDUS examination in people with Choledocholithiasis and Cholangiopancreatography, Endoscopic Retrograde, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP. Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Ultrasonography
- What is being tested?
- IDUS examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 2 Nov 2021to 16 Apr 2026
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.Clinical diagnosis of common bile duct stones 2.At least one of the following, diameter of CBD>1.5cm, or number of calculi>2, or lithotripsy during ercp
Who cannot join
- 1. Clinical diagnosis of liver or biliary malignant tumor. 2. Clinical diagnosis of duodenal malignant tumor 3. Failure or unexpected termination of ERCP 4. Surgery history of gallbladder or bile duct.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Practical Value of IDUS in Patients With High Risk of Recurrence of Common Bile Duct Stones After ERCP Lithotomy
This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
Read the detailed description
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
High risks were defined as diameter of CBD>1.5cm, number of calculi>2, and lithotripsy.
Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
- Being tested
- IDUS examination
- Keywords
- Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Ultrasonography, Bile Ducts
- Medical subject headings
- Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDUS examinationProcedure or surgery
for patients with high risks of bile duct stones recurrence using IDUS during ERCP
| Study group | Role | What they receive |
|---|---|---|
| IDUS examination during ERCP | Experimental | CBD stones cases with high recurrence risks apply IDUS during ERCP Receives: Procedure: IDUS examination |
| Control | No intervention | CBD stones cases with high recurrence risks don't apply IDUS during ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence of bile duct stone or cholangitis
patients will be followed up for 48 weeks to record the recurrence of CBD stones or cholangitis
Measured: 48 weeks
need for a nasobiliary tube
it's a Yes or No categorical variable to describe if the patient was placed a nasobiliary tube during ERCP
Measured: 2 weeks
need for stents
it's a Yes or No categorical variable to describe if stents were deployed during ERCP
Measured: 4 weeks
Secondary outcomes (14)
operation time
the time from tracheal intubation to the end of ERCP was recorded
Measured: intraoperative
radiation time
radiation time of each patient was recorded
Measured: 4 weeks
hospitalization cost
hospitalization cost of each patient was recorded
Measured: 8 weeks
Questionnaire of Symptoms and conditions after ERCP
Questionnaire of symptoms and conditions after ERCP were recorded. Degree of abdominal pain and distension were recorded with a highest level of three points respectively.
Measured: 8 weeks
White blood cell count
Routine blood test
Measured: 12 weeks
Red blood cell count
Routine blood test
Measured: 12 weeks
Platelet count
Routine blood test
Measured: 12 weeks
total bilirubin, direct bilirubin
Liver function test
Measured: 12 weeks
Liver function test (ALT, AST)
Measured: 12 weeks
albumin
Liver function test
Measured: 12 weeks
total protein
Liver function test
Measured: 12 weeks
Gamma-glutamyl transferase (GGT) test
Liver function test
Measured: 12 weeks
An alkaline phosphatase (ALP) test
Liver function
Measured: 12 weeks
whether have a resection of gallbladder checklist
whether the patient has a resection of gallbladder after ERCP
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start2 Nov 2021
- Primary completion31 Jan 2024
- Study completion16 Apr 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Hang, Shanghai Municipal Hospital of Traditional Chinese Medicine
- Investigators
- Hang Zhao, PhD, Principal investigator, Shanghai Municipal Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265311
- Sponsor's protocol ID
- 20221307-2
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2022
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Value of IDUS in Patients With High Risk of Recurrence of Common Bile Duct Stones After ERCP Lithotomy
- ClinicalTrials.gov ID
- NCT06265311
- Acronym / sponsor ID
- 20221307-2
- Keywords
- Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde, Ultrasonography, Bile Ducts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Shanghai Municipal Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 16 Apr 2026 (actual)
- First posted
- 20 Feb 2024 (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.
This study is designed to observed CBD stones cases with high recurrence risks applying IDUS or not during ERCP.
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
Detailed description
Patients with CBD stone high recurrence risks were enrolled in this study, and prospectively randomized into IUDS group and control group during lithotomy.
High risks were defined as diameter of CBD>1.5cm, number of calculi>2, and lithotripsy.
Operation time, radiation time, hospitalization cost, retain of nasobiliary tube, deployment of stent were recorded.
Symptoms and conditions after ERCP were also followed up including blood amylase, routine blood test, abdominal pain, post-ERCP pancreatitis, resection of gallbladder, recurrence of CBD stone and onset of cholangitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDUS examination during ERCP | Experimental | Procedure: IDUS examinationCBD stones cases with high recurrence risks apply IDUS during ERCP |
| Control | No intervention | –CBD stones cases with high recurrence risks don't apply IDUS during ERCP |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.Clinical diagnosis of common bile duct stones 2.At least one of the following, diameter of CBD>1.5cm, or number of calculi>2, or lithotripsy during ercp
Key exclusion criteria (1 listed)
- 1. Clinical diagnosis of liver or biliary malignant tumor. 2. Clinical diagnosis of duodenal malignant tumor 3. Failure or unexpected termination of ERCP 4. Surgery history of gallbladder or bile duct.
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 |
|---|---|---|
| IDUS examinationfor patients with high risks of bile duct stones recurrence using IDUS during ERCP | Procedure or surgery | IDUS examination during ERCP |
Primary outcome
recurrence of bile duct stone or cholangitis
Time frame: 48 weeks
patients will be followed up for 48 weeks to record the recurrence of CBD stones or cholangitis
need for a nasobiliary tube
Time frame: 2 weeks
it's a Yes or No categorical variable to describe if the patient was placed a nasobiliary tube during ERCP
need for stents
Time frame: 4 weeks
it's a Yes or No categorical variable to describe if stents were deployed during ERCP
14 secondary outcomes
operation time
Time frame: intraoperative
radiation time
Time frame: 4 weeks
hospitalization cost
Time frame: 8 weeks
Questionnaire of Symptoms and conditions after ERCP
Time frame: 8 weeks
White blood cell count
Time frame: 12 weeks
Red blood cell count
Time frame: 12 weeks
Platelet count
Time frame: 12 weeks
total bilirubin, direct bilirubin
Time frame: 12 weeks
Liver function test (ALT, AST)
Time frame: 12 weeks
albumin
Time frame: 12 weeks
total protein
Time frame: 12 weeks
Gamma-glutamyl transferase (GGT) test
Time frame: 12 weeks
An alkaline phosphatase (ALP) test
Time frame: 12 weeks
whether have a resection of gallbladder checklist
Time frame: 48 weeks
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 20 Apr 2026.
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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.
Hang Zhao, PhD principal investigator
Shanghai Municipal Traditional Chinese Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IDUS examination in people with Choledocholithiasis and Cholangiopancreatography, Endoscopic Retrograde, run by Shanghai Municipal Hospital of Traditional Chinese Medicine at 1 site in China.
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 20 Apr 2026. 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 China. 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?
recurrence of bile duct stone or cholangitis (time frame: 48 weeks). The study lists 3 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 20 Apr 2026.