Biliary and pancreatic diseases
Conditions
Interventions
Test group:Using a natural orifice ERCP instrument control system to assist in the remote delivery, manipulation, and retrieval of instruments during endoscopic retrograde cholangiopancreatography
Sponsors
The First People's Hospital,School of Medicine,Westlake University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, regardless of gender; 2.Assessed by a clinician and meeting the following ERCP indications: According to the Chinese ERCP Guidelines (2018 Edition), the subject meets the following diagnostic criteria and is eligible for clinical research indications of endoscopic retrograde cholangiopancreatography: (1)Common bile duct stones (symptomatic or asymptomatic); (2)Removal/replacement/extraction of biliary stents; (3)Obstructive suppurative cholangitis; (4)Biliary strictures (benign or malignant) requiring drainage; (5)Biliary or recurrent pancreatitis. 3.The subject is willing to comply with the protocol requirements and data collection procedures; able to understand the purpose of the study, and voluntarily participates by providing informed consent signed by themselves or their legal guardian.
Exclusion criteria
Exclusion criteria: 1.The subject has contraindications for endoscopic retrograde cholangiopancreatography (ERCP) according to the guidelines; 2.Severe and uncorrectable hepatic or renal dysfunction; 3.Impaired consciousness, dementia, psychiatric disorders, or other mental abnormalities; 4.Pregnant or lactating women, or women planning to become pregnant during the clinical trial period; 5.History of stroke or myocardial infarction within 30 days prior to surgery; 6.Recent active ulcer, upper gastrointestinal bleeding, or coagulation disorders; 7.Active infection, persistent fever, or similar conditions; 8.The investigator deems the subject unsuitable for robot-assisted surgery; 9.The subject has participated in other clinical studies within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical success;Procedural success; | — |
Secondary
| Measure | Time frame |
|---|---|
| Total radiation exposure per procedure;Usability Evaluation of the Natural Orifice ERCP Instrument Control System; | — |
Countries
China
Contacts
Public ContactZhang Xiaofeng
The First People's Hospital,School of Medicine,Westlake University
Outcome results
None listed