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Comparison of the efficacy of IT knife nano pre-cut papillotomy assisted method and conventional method with standard catheter and guidewire in selective bile duct intubation: a multicenter prospective randomized controlled study

Comparison of the efficacy of IT knife nano pre-cut papillotomy assisted method and conventional method with standard catheter and guidewire in selective bile duct intubation: a multicenter prospective randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036394
Enrollment
Unknown
Registered
2020-08-22
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

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

Conditions

common bile duct stones

Interventions

IT knife nano group:IT knife nano pre-cut papillotomy assisted intubation
conventional group:conventional method with standard catheter and guidewire

Sponsors

Nanjing Drum Tower Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Preoperative diagnosis of choledocholithiasis patients with papillary sphincterotomy; 2. Patients treated with ERCP for the first time; 3. Patients aged 18 to 65 years old; 4. The subjects voluntarily participated in the experiment and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with coagulation dysfunction; 2. Patients with diverticulum or diverticulum marginal papillae affecting intubation; 3. Patients with ERCP after digestive tract diversion; 4. Patients with incarcerated papillary stones; 5. Patients with heart, lung or liver failure; 6. Patients with acute obstructive suppurative cholangitis treated by ERCP; 7. The papillary lesions, small and flat, unclear structure or covered by duodenal plica after endoscopy, the operator judged that it was difficult to pre cut with small it knife.

Design outcomes

Primary

MeasureTime frame
success rate of intubation;intubation time;

Secondary

MeasureTime frame
post-ERCP pancreatitis;ERCP related bleeding;perforation;cholangitis;

Countries

China

Contacts

Public ContactXiaoping Zou

Nanjing Drum Tower Hospital

13770771661@163.com+86 13770771661

Outcome results

None listed

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