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

Sponsor

Air Force Military Medical University, China (Other)

Overall Status

Completed

CT.gov ID

NCT02697149

Collaborator

(none)

219

Enrollment

Locations

Duration (Months)

109.5

Patients Per Site

27.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endoscopic Retrograde Cholangiopancreatography , Gallstone	Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography Radiation: standard endoscopic retrograde cholangiopancreatography

Study Design

Study Type:

Observational

Actual Enrollment :

219 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Dec 1, 2015

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
intervention patients undergoing nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography	Radiation: nonradiation-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.
control patients undergoing standard endoscopic retrograde cholangiopancreatography	Radiation: standard endoscopic retrograde cholangiopancreatography Patients received standard endoscopic retrograde cholangiopancreatography. Fluoroscopy was normally used when necessary.

Arm

Intervention/Treatment

intervention

patients undergoing nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography

Radiation: nonradiation-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.

control

patients undergoing standard endoscopic retrograde cholangiopancreatography

Radiation: standard endoscopic retrograde cholangiopancreatography

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

Outcome Measures

Primary Outcome Measures

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

Overall complications [6 months]
Post-endoscopic retrograde cholangiopancreatography pancreatitis, bleeding, perforation, infection of biliary tract
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
ERCP procedure time [6 months]
defined by the interval time between scope insertion and complete of endoscopic retrograde cholangiopancreatography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of gastroenterology, Chinese PLA 174 Hospital	Xiamen	Fujian	China	361001
2	Xijing Hospital of Digestive Diseases	Xi'an	Shaanxi	China	710032

Sponsors and Collaborators

Air Force Military Medical University, China

Investigators

Principal Investigator: Yanglin Pan, M.D., Air Force Military Medical University, China
Principal Investigator: Wei Zeng, M.D., Department of gastroenterology, Chinese PLA 174 hospital