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RecruitingNCT06978231EUS、 ERCPUpdated Sep 9, 2025

Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases

An interventional study of EUS+ERCP and ERCP in Pancreaticobiilary Diseases, sponsored by Qilu Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-09.

Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
214
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a single-center randomized controlled trial. Eligible subjects meeting inclusion/exclusion criteria will be randomized 1:1 to EUS+ERCP group or ERCP group. Clinical data and patient-reported outcomes are regularly collected at baseline and during follow-up periods. A comparative analysis was conducted to assess the impact of same-session EUS on ERCP strategy modification between two groups, utilizing a structured questionnaire.Secondarily, the safety and efficacy of same-session EUS will be comprehensively evaluated by comparing complication rates, technical success rate and hospitalization costs, length of stay, and radiation exposure between groups.

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Conditions studied

  • Pancreaticobiilary Diseases
03

In context

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
214 participants (estimated)

Study arms

  • Experimental
    EUS+ERCP group

    EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group.

    Procedure: EUS+ERCP

  • Other
    ERCP group

    Only ERCP was performed in the control group

    Procedure: ERCP

Interventions

  • ProcedureEUS+ERCP

    EUS were performed during the same session with ERCP under continuous sedation/anesthesia

  • ProcedureERCP

    Only ERCP was performed in the control group

06

What researchers measure

Primary outcomes

  1. ERCP strategy modification rate

    Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.

    Time frame: From enrollment to 6 months after the end of treatment

Secondary outcomes

  1. Procedure outcomes

    Technical success rate (defined as successful completion of intended therapeutic intervention) ERCP procedure time (from duodenoscope insertion to withdrawal) Difficult cannulation rate (requiring advanced techniques or \>5 attempts)

    Time frame: From enrollment to 6 months after the end of treatment

  2. Incidence of complications

    Time frame: From enrollment to 6 months after the end of treatment

  3. Radiation-related situation

    Fluoroscopy time (minutes) Radiation exposure (dose-area product, Gy·cm²)

    Time frame: From enrollment to 6 months after the end of treatment

  4. Healthcare utilization measures

    Hospital length of stay (days) Total hospitalization costs

    Time frame: From enrollment to 6 months after the end of treatment

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250000, China
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06978231
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Sponsor
First posted
May 18, 2025
Start date
Jun 10, 2025
Primary completion
Dec 2026 (estimated)
Completion
Apr 2027 (estimated)
Last update
Sep 9, 2025

Study contacts

Zhen Li, MD,PhD
Contact
qilulizhen@sdu.edu.cn
+86 18560086106

Oversight

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

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