Endoscopic Retrograde Cholangiopancreatography , Gallstone Clinical Trial
Official title:
The Effectiveness and Safety of Nonradiation-to-endoscopist Endoscopic Retrograde Cholangiopancreatography in Patients With Complexity Level I/II
| Verified date | July 2016 |
| Source | Fourth Military Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | China: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 219 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - 18-90 years old - patients undergoing endoscopic retrograde cholangiopancreatography Exclusion Criteria: - 1 Bismuth typy ? and ? - 2 common bile duct stone > 15mm - 3 common bile duct stone and distal stenosis |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| China | Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi |
| China | Department of gastroenterology, Chinese PLA 174 Hospital | Xiamen | Fujian |
| Lead Sponsor | Collaborator |
|---|---|
| Fourth Military Medical University |
China,
Liao C, Thosani N, Kothari S, Friedland S, Chen A, Banerjee S. Radiation exposure to patients during ERCP is significantly higher with low-volume endoscopists. Gastrointest Endosc. 2015 Feb;81(2):391-8.e1. doi: 10.1016/j.gie.2014.08.001. Epub 2014 Oct 5. — View Citation
Uradomo LT, Goldberg EM, Darwin PE. Time-limited fluoroscopy to reduce radiation exposure during ERCP: a prospective randomized trial. Gastrointest Endosc. 2007 Jul;66(1):84-9. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | Overall complications | Post-endoscopic retrograde cholangiopancreatography pancreatitis, bleeding, perforation, infection of biliary tract | 6 months | No |
| Secondary | 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 | No |
| Secondary | ERCP procedure time | defined by the interval time between scope insertion and complete of endoscopic retrograde cholangiopancreatography | 6 months | No |