Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II

Completed

• Conditions: Endoscopic Retrograde Cholangiopancreatography , Gallstone
• Interventions: Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography; Radiation: standard endoscopic retrograde cholangiopancreatography

• Registration Number: NCT02697149
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

Radiation exposure may put endoscopists at risk when performing endoscopic retrograde cholangiopancreatography. Although non-radiation endoscopic retrograde cholangiopancreatography was reported in pregnant women in previous reports, it remains unclear whether endoscopic retrograde cholangiopancreatography is also effective and safe when endoscopists were not expose to radiation. This study was to evaluate the effectiveness and safety of nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography in patients with complexity level I/II.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-17
• Study First Submitted QC: 2016-02-28
• Study First Posted: 2016-03-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

Inclusion Criteria

• 18-90 years old
• patients undergoing endoscopic retrograde cholangiopancreatography

Exclusion Criteria

• 1 Bismuth typy Ⅲ and Ⅳ
• 2 common bile duct stone > 15mm
• 3 common bile duct stone and distal stenosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intervention	nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography	patients undergoing nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography
control	standard endoscopic retrograde cholangiopancreatography	patients undergoing standard endoscopic retrograde cholangiopancreatography

Primary Outcome Measures

Name	Time	Method
Success of endoscopic retrograde cholangiopancreatography	6 months	The success is defined by complete removal of common bile duct stones or placement of stents in proper position.

Secondary Outcome Measures

Name	Time	Method
Cannulation success rate	6 months	In patients with native papilla, cannulation success rate was defined as the proportion of subjects with successful cannulation of targeted duct
Overall complications	6 months	Post-endoscopic retrograde cholangiopancreatography pancreatitis, bleeding, perforation, infection of biliary tract
ERCP procedure time	6 months	defined by the interval time between scope insertion and complete of endoscopic retrograde cholangiopancreatography

Trial Locations

Locations (2)

Department of gastroenterology, Chinese PLA 174 Hospital; 🇨🇳 Xiamen, Fujian, China

Xijing Hospital of Digestive Diseases; 🇨🇳 Xi'an, Shaanxi, China