JRCT ID: jRCT1030250433
Registered date:15/10/2025
Simultaneous EUS and ERCP-related procedures using a novel oblique-veiwing convex EUS
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Biliary tract disorders, Pancreartic disorders |
| Date of first enrollment | 15/10/2025 |
| Target sample size | 92 |
| Countries of recruitment | |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Success rate of ERCP-related procedures performed using a oblique-viewing convex-array echoendoscope in cases where both ERCP- and EUS-related procedures are conducted. |
|---|---|
| Secondary Outcome | 1) Overall success rate of ERCP-related procedures, including cases in which the duodenoscope was used instead (including procedures performed on different days). 2) Success rate of EUS-related procedures. 3) Details of alternative treatments and overall final procedural success rate (including procedures performed on different days) in cases where ERCP-related procedures were unsuccessful. 4) Procedure time for ERCP-related and EUS-related procedures. 5) Type, severity, and management of early adverse events occurring within 14 days after the procedure. 6) Analysis of factors contributing to the success rate of ERCP-related procedures performed using a forward-viewing convex-array echoendoscope. |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | Not applicable |
| Gender | |
| Include criteria | 1) Patients undergoing their first ERCP in whom both ERCP-related and EUS-related procedures using a oblique-viewing convex-array echoendoscope are planned to be performed in the same session. 2) Patients aged 18 years or older at the time of obtaining informed consent. 3) Patients who have received a full explanation about this study, have fully understood the information, and have provided written informed consent of their own free will. |
| Exclude criteria | 1) Patients who have previously undergone any procedure involving the duodenal papilla 2) Patients with a history of gastrointestinal reconstruction other than Billroth 1 gastrectomy. 3) Patients with a bleeding tendency. 4) Patients at high risk of thromboembolism for whom discontinuation or substitution of antithrombotic agents is not possible according to the guidelines for Gastrointestinal Endoscopy in Patients Undergoing Antithrombotic Treatment. 5) Patients with heart failure or respiratory failure . 6) Patients who are pregnant or may possibly be pregnant. 7) Patients who are unable to provide written informed consent or who withdraw their consent. 8) Any other patients deemed inappropriate for inclusion by the principal investigator. |
Related Information
| Primary Sponsor | Matsubara Saburo |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Saburo Matsubara |
| Address | 1981, Kamoda, Kawagoe-shi, Saitama Saitama Japan 350-8550 |
| Telephone | +81-49-228-3400 |
| saburo.matsubara@gmail.com | |
| Affiliation | Saitama Medical Center, Saitama Medical University |
| Scientific contact | |
| Name | Saburo Matsubara |
| Address | 1981, Kamoda, Kawagoe-shi, Saitama Saitama Japan 350-8550 |
| Telephone | +81-49-228-3400 |
| saburo.matsubara@gmail.com | |
| Affiliation | Saitama Medical Center, Saitama Medical University |