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Ultrasound boost for bile duct procedures: could save patients from unnecessary surgery

NCT ID NCT06978231

Knowledge-focused Sponsor: Qilu Hospital of Shandong University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study looks at whether doing an endoscopic ultrasound (EUS) at the same time as a standard bile duct procedure (ERCP) helps doctors make better treatment choices. 214 adults with pancreatic or bile duct diseases will be randomly assigned to get either the combined procedure or ERCP alone. Researchers will compare how often the treatment plan changes, complication rates, and hospital costs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could show that adding an ultrasound to a standard bile duct procedure helps doctors make better treatment decisions and avoid unnecessary procedures.
What could go wrong
This is a single-center study with 214 participants, so results may not apply broadly. The main benefit is about improving decision-making, not a direct cure or treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 214 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients aged ≥18 years; 2. Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists ); 3. No prior history of ERCP; 4. No pancreaticobiliary EUS examinations within the preceding 3 months. Exclusion Criteria: 1. Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance; 2. Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ; 3. Patients with anatomical alterations or surgical history affecting EUS feasibility; 4. Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures; 5. Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP); 6. Pregnancy or lactation; 7. Patients with severe coagulopathy; 8. Declined informed consent; 9. Severe psychiatric disorder/non-cooperation precluding safe procedure.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreaticobiilary diseases

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250000, China