Pancreaticobiilary DiseasesEUS、 ERCPNCT06978231
Effect of Same-session EUS on ERCP in Pancreaticobiliary Diseases
A study testing EUS+ERCP and ERCP in people with Pancreaticobiilary Diseases, run by Qilu Hospital of Shandong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreaticobiilary Diseases
- What is being tested?
- EUS+ERCP and ERCP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2025to Apr 2027
- 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
Who may be able to join
- Patients aged ≥18 years;
- Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists );
- No prior history of ERCP;
- No pancreaticobiliary EUS examinations within the preceding 3 months.
Who cannot join
- Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance;
- Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ;
- Patients with anatomical alterations or surgical history affecting EUS feasibility;
- Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures;
- Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP);
- Pregnancy or lactation;
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- Patients with severe coagulopathy;
- Declined informed consent;
- Severe psychiatric disorder/non-cooperation precluding safe procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong, 250000
Zhen Li, MD, 18560086106, lizhenh@hotmail.com
About this study
Official title: Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
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.
- Conditions
- Pancreaticobiilary Diseases
- Being tested
- EUS+ERCP, ERCP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS+ERCPProcedure or surgery
EUS were performed during the same session with ERCP under continuous sedation/anesthesia
ERCPProcedure or surgery
Only ERCP was performed in the control group
| Study group | Role | What they receive |
|---|---|---|
| EUS+ERCP group | Experimental | EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group. Receives: Procedure: EUS+ERCP |
| ERCP group | Other | Only ERCP was performed in the control group Receives: Procedure: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
ERCP strategy modification rate
Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.
Measured: From enrollment to 6 months after the end of treatment
Secondary outcomes (4)
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)
Measured: From enrollment to 6 months after the end of treatment
Incidence of complications
Measured: From enrollment to 6 months after the end of treatment
Radiation-related situation
Fluoroscopy time (minutes) Radiation exposure (dose-area product, Gy·cm²)
Measured: From enrollment to 6 months after the end of treatment
Healthcare utilization measures
Hospital length of stay (days) Total hospitalization costs
Measured: From enrollment to 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start10 Jun 2025
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreaticobiilary DiseasesStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978231
- Sponsor's protocol ID
- 2025SDU-QILU-3
- Acronym
- EUS、 ERCP
- Status last verified
- Jun 2025
- First submitted
- 10 May 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Same-session Endoscopic Ultrasonography on Endoscopic Retrograde Cholangiopancreatography in Pancreaticobiliary Diseases: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06978231
- Acronym / sponsor ID
- EUS、 ERCP / 2025SDU-QILU-3
- Conditions
- Pancreaticobiilary Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 18 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS+ERCP group | Experimental | Procedure: EUS+ERCPEUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group. |
| ERCP group | Other | Procedure: ERCPOnly ERCP was performed in the control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged ≥18 years;
- Patients with pancreaticobiliary diseases definitively indicated for ERCP (as confirmed by HBP Specialists );
- No prior history of ERCP;
- No pancreaticobiliary EUS examinations within the preceding 3 months.
Key exclusion criteria (9 listed)
- Patients with clinically confirmed malignant lesions deemed surgically unresectable by multidisciplinary evaluation and requiring pathological diagnosis exclusively for chemotherapy/radiotherapy guidance;
- Patients with confirmed diagnosis requiring only palliative biliary/pancreatic stent placement for obstructive jaundice ;
- Patients with anatomical alterations or surgical history affecting EUS feasibility;
- Severe systemic illness including severe hepatic, renal, cardiopulmonary and cerebrovascular diseases with high risk for endoscopic procedures;
- Contraindication to iodinated contrast media (allergy or renal impairment preventing ERCP);
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 |
|---|---|---|
| EUS+ERCPEUS were performed during the same session with ERCP under continuous sedation/anesthesia | Procedure or surgery | EUS+ERCP group |
| ERCPOnly ERCP was performed in the control group | Procedure or surgery | ERCP group |
Primary outcome
ERCP strategy modification rate
Time frame: From enrollment to 6 months after the end of treatment
Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures.
4 secondary outcomes
Procedure outcomes
Time frame: From enrollment to 6 months after the end of treatment
Incidence of complications
Time frame: From enrollment to 6 months after the end of treatment
Radiation-related situation
Time frame: From enrollment to 6 months after the end of treatment
Healthcare utilization measures
Time frame: From enrollment to 6 months after the end of treatment
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 9 Sep 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS+ERCP and ERCP in people with Pancreaticobiilary Diseases, run by Qilu Hospital of Shandong University 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 9 Sep 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 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?
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 Zhen Li, MD,PhD (+86 18560086106, qilulizhen@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ERCP strategy modification rate (time frame: From enrollment to 6 months after the end of treatment). 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 9 Sep 2025.