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Evaluation of the Safety and Efficacy of Multidimensional Intelligent Imaging Cholangiopancreatoscopy: A Randomized Controlled Trial

Evaluation of the Safety and Efficacy of Multidimensional Intelligent Imaging Cholangiopancreatoscopy: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110710
Enrollment
Unknown
Registered
2025-10-20
Start date
2025-10-27
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suspected Biliary and Pancreatic Duct Diseases (e.g., stones, strictures, tumors, etc.)

Interventions

Control Group:Fibreoptic cholangioscopy assisted ERCP for direct visualisation
Intervention Group:Memory material sheath guide, direct insertion into the biliopancreatic duct, combined with multi-dimensional intelligent imaging for examination

Sponsors

Beijing Friendship Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with suspected biliopancreatic duct diseases (e.g., stones, strictures, tumors) requiring ERCP for etiological diagnosis; 2.Age 18 years or older; 3.Willingness to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. During pregnancy; 2. Those who are unable to tolerate surgery such as severe coagulation disorders, severe cardiopulmonary and other organic diseases; 3. postoperative partial gastrectomy and postoperative gastrointestinal diversion; 4. conditions that should be excluded in the opinion of the investigator.

Design outcomes

Primary

MeasureTime frame
Cannulation success rate after sphincterotomy;

Secondary

MeasureTime frame
Operability;Operation time;Adverse Event Rate;Complication Rate;Image Clarity;

Countries

China

Contacts

Public ContactZhang Shutian

Beijing Friendship Hospital ,Capital Medical University

zhangshutian@cmu.edu.cn+86 10 63139351

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026