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CompletedNCT06265311Updated Apr 20, 2026

IDUS in CBD Stone Recurrence High Risk Patients

An interventional study of IDUS examination in Choledocholithiasis, Cholangiopancreatography, Endoscopic Retrograde and Ultrasonography, sponsored by Shanghai Municipal Hospital of Traditional Chinese Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Shanghai Municipal Hospital of Traditional Chinese Medicine · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Nov 2021, registered Dec 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
248
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Choledocholithiasis
  • Cholangiopancreatography, Endoscopic Retrograde
  • Ultrasonography

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Keywords

  • Choledocholithiasis
  • Cholangiopancreatography, Endoscopic Retrograde
  • Ultrasonography
  • Bile Ducts
03

In context

Choledocholithiasis

109 studies on the registry are indexed under Choledocholithiasis; 24 are open to participants now.

This study's enrollment of 248 is above the median of 100 across 76 interventional studies indexed under Choledocholithiasis.

Browse Choledocholithiasis studies →

Lead sponsor

Shanghai Municipal Hospital of Traditional Chinese Medicine is the lead sponsor of 14 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
248 participants (actual)

Study arms

  • Experimental
    IDUS examination during ERCP

    CBD stones cases with high recurrence risks apply IDUS during ERCP

    Procedure: IDUS examination

  • No intervention
    Control

    CBD stones cases with high recurrence risks don't apply IDUS during ERCP

Interventions

  • ProcedureIDUS examination

    for patients with high risks of bile duct stones recurrence using IDUS during ERCP

06

What researchers measure

Primary outcomes

  1. recurrence of bile duct stone or cholangitis

    patients will be followed up for 48 weeks to record the recurrence of CBD stones or cholangitis

    Time frame: 48 weeks

  2. 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

    Time frame: 2 weeks

  3. need for stents

    it's a Yes or No categorical variable to describe if stents were deployed during ERCP

    Time frame: 4 weeks

Secondary outcomes

  1. operation time

    the time from tracheal intubation to the end of ERCP was recorded

    Time frame: intraoperative

  2. radiation time

    radiation time of each patient was recorded

    Time frame: 4 weeks

  3. hospitalization cost

    hospitalization cost of each patient was recorded

    Time frame: 8 weeks

  4. 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.

    Time frame: 8 weeks

  5. White blood cell count

    Routine blood test

    Time frame: 12 weeks

  6. Red blood cell count

    Routine blood test

    Time frame: 12 weeks

  7. Platelet count

    Routine blood test

    Time frame: 12 weeks

  8. total bilirubin, direct bilirubin

    Liver function test

    Time frame: 12 weeks

  9. Liver function test (ALT, AST)

    Time frame: 12 weeks

  10. albumin

    Liver function test

    Time frame: 12 weeks

  11. total protein

    Liver function test

    Time frame: 12 weeks

  12. Gamma-glutamyl transferase (GGT) test

    Liver function test

    Time frame: 12 weeks

  13. An alkaline phosphatase (ALP) test

    Liver function

    Time frame: 12 weeks

  14. whether have a resection of gallbladder checklist

    whether the patient has a resection of gallbladder after ERCP

    Time frame: 48 weeks

07

Study locations

1 site
  • Shang General Hospital
    Shanghai, 200080, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2021 to primary completion in Jan 2024, 26 months.

Of 41 non-industry interventional studies with no phase under Choledocholithiasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 36. This study's 26 months is above that.

Counting every sponsor, half of 43 studies reached it within 21 months; a quarter within 12 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2022
First posted
Feb 20, 2024
StartActual
Nov 2, 2021
Primary completionActual
Jan 31, 2024
CompletionActual
Apr 16, 2026
Last update
Apr 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06265311
Lead sponsor
Shanghai Municipal Hospital of Traditional Chinese Medicine
Responsible party
Zhao Hang (Director of Department of Gastroenterology, Shanghai Municipal Hospital of Traditional Chinese Medicine) — Principal investigator
First posted
Feb 20, 2024
Start date
Nov 2, 2021
Primary completion
Jan 31, 2024
Completion
Apr 16, 2026
Last update
Apr 20, 2026

Study contacts

Hang Zhao, PhD
principal investigator · Shanghai Municipal Traditional Chinese Medicine Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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