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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02697149
Enrollment
219
Registered
2016-03-03
Start date
2015-12-31
Completion date
2016-04-30
Last updated
2016-07-21

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

Conditions

Endoscopic Retrograde Cholangiopancreatography , Gallstone

Keywords

ERCP, nonradiation-to-endoscopist, gallstones

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.

Interventions

RADIATIONnonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography

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.

RADIATIONstandard endoscopic retrograde cholangiopancreatography

Patients received standard endoscopic retrograde cholangiopancreatography. Fluoroscopy was normally used when necessary.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Success of endoscopic retrograde cholangiopancreatography6 monthsThe success is defined by complete removal of common bile duct stones or placement of stents in proper position.

Secondary

MeasureTime frameDescription
Overall complications6 monthsPost-endoscopic retrograde cholangiopancreatography pancreatitis, bleeding, perforation, infection of biliary tract
Cannulation success rate6 monthsIn patients with native papilla, cannulation success rate was defined as the proportion of subjects with successful cannulation of targeted duct
ERCP procedure time6 monthsdefined by the interval time between scope insertion and complete of endoscopic retrograde cholangiopancreatography

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026