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Multicenter Prospective Study on the Success Rate and Safety of ERCP Papillary Insertion of the "Clock Rotation Catheterization Technique"

Multicenter Prospective Study on the Success Rate and Safety of ERCP Papillary Insertion of the “Clock Rotation Catheterization Technique”

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119765
Enrollment
Unknown
Registered
2026-03-03
Start date
2026-03-15
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

Cholecystopancreatic disease

Interventions

Experimental group:Clock Rotation catheterization
Control group:Conventional catheterization

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years and <= 70 years; 2.Voluntary and have signed the informed consent form for this clinical trial; 3.Clinically diagnosed with biliary or pancreatic diseases such as common bile duct stones, bile duct stenosis, acute biliary pancreatitis, etc., or requiring further diagnosis due to suspected biliary or pancreatic system diseases, and meeting the indications for ERCP; 4.Able to follow the 12-month visit plan and regularly return for follow-up according to the clinical trial research protocol; 5.Able to objectively describe symptoms and actively cooperate in completing the filling of relevant assessment scales; 6.No allergic diseases, no history of iodine contrast agent allergy; 7.Non-pregnant and non-pregnant women, and subjects who have no pregnancy plans within 3 months after the clinical trial; 8.Participated in this clinical trial within 3 months without participating in any other clinical trials; 9.If taking long-term anticoagulant drugs (such as aspirin, clopidogrel, warfarin, new oral anticoagulants, etc.), the drugs need to be discontinued for 5-7 days;

Exclusion criteria

Exclusion criteria: 1.Severe functional impairments of organs such as heart, brain, and lungs, making them unable to tolerate ERCP treatment; 2.Iodine contrast agent allergy; 3.Presence of coagulation dysfunction (INR > 1.3) and significant reduction in peripheral platelet count (< 50 × 10^9/L); 4.Complicated with severe liver diseases, intrahepatic bile duct stones, etc. 5.Having liver-biliary-pancreatic system tumors; 6.Having previously undergone ERCP; 7.Having undergone digestive tract reconstruction surgery; 8.Having other contraindications for ERCP examination and treatment;

Design outcomes

Primary

MeasureTime frame
Success rate of catheterization;

Secondary

MeasureTime frame
Period of catheterization;The average length of stay;Pain symptom score of patients;The incidence of complications one week after the operation;Period of operation;X-ray exposure time;

Countries

China

Contacts

Public ContactHu Ye

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

huye327@126.com+86 21 25077130

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026