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

Study Overview
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Brief Summary
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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.

Official Title
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The Effectiveness and Safety of Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II

Conditions
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Endoscopic Retrograde Cholangiopancreatography , Gallstone

Intervention / Treatment
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* Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography
* Radiation: standard endoscopic retrograde cholangiopancreatography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| intervention<br>patients undergoing nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography | Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography<br>* All patients received magnetic resonance cholangiopancreatography before the procedure. Characteristics of lesions (e.g. common bile duct stones, stenosis) in detail was identified. During the procedure, the endoscopist was not exposed to radiation. If fluoroscopy was needed, after contrast injection (sometimes not necessary), the endoscopist went outside of the operation room and observed the X-ray image by remote control of the fluoroscopy machine.<br>|
| control<br>patients undergoing standard endoscopic retrograde cholangiopancreatography | Radiation: standard endoscopic retrograde cholangiopancreatography<br>* Patients received standard endoscopic retrograde cholangiopancreatography. Fluoroscopy was normally used when necessary.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of endoscopic retrograde cholangiopancreatography | The success is defined by complete removal of common bile duct stones or placement of stents in proper position. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, nonradiation-to-endoscopist, gallstones