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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EUS+ERCP group | Experimental | EUS and ERCP were performed during the same session under continuous sedation/anesthesia in the intervention group. |
|
| ERCP group | Other | Only ERCP was performed in the control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS+ERCP | Procedure | EUS were performed during the same session with ERCP under continuous sedation/anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| ERCP strategy modification rate | Concordance rate between anticipated and actual ERCP procedural strategies and the rate of avoiding unnecessary ERCP procedures. | From enrollment to 6 months after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From enrollment to 6 months after the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhen Li, MD,PhD | Contact | +86 18560086106 | qilulizhen@sdu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Recruiting | Jinan | Shandong | 250000 | China |
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| ID | Term |
|---|---|
| D002760 | Cholangiopancreatography, Endoscopic Retrograde |
| ID | Term |
|---|---|
| D002758 | Cholangiography |
| D011860 | Radiography, Abdominal |
| D011859 | Radiography |
| D003952 | Diagnostic Imaging |
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| ERCP | Procedure | Only ERCP was performed in the control group |
|
| Incidence of complications |
| From enrollment to 6 months after the end of treatment |
| Radiation-related situation | Fluoroscopy time (minutes) Radiation exposure (dose-area product, Gy·cm²) | From enrollment to 6 months after the end of treatment |
| Healthcare utilization measures | Hospital length of stay (days) Total hospitalization costs | From enrollment to 6 months after the end of treatment |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003938 | Diagnostic Techniques, Digestive System |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |