NIPH Clinical Trials Search

JAPANESE
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) studiedBiliary tract disorders, Pancreartic disorders
Date of first enrollment15/10/2025
Target sample size92
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeSuccess 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 Outcome1) 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 maximumNot applicable
Gender
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name Saburo Matsubara
Address 1981, Kamoda, Kawagoe-shi, Saitama Saitama Japan 350-8550
Telephone +81-49-228-3400
E-mail 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
E-mail saburo.matsubara@gmail.com
Affiliation Saitama Medical Center, Saitama Medical University