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

NCT ID: NCT02697149

Last Updated: 2016-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-04-30

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.

Detailed Description

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Conditions

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Endoscopic Retrograde Cholangiopancreatography , Gallstone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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intervention

patients undergoing nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography

nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography

Intervention Type RADIATION

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

standard endoscopic retrograde cholangiopancreatography

Intervention Type RADIATION

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

Interventions

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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.

Intervention Type RADIATION

standard endoscopic retrograde cholangiopancreatography

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

Intervention Type RADIATION

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Air Force Military Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Yanglin Pan

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yanglin Pan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Air Force Military Medical University, China

Wei Zeng, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of gastroenterology, Chinese PLA 174 hospital

Locations

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Department of gastroenterology, Chinese PLA 174 Hospital

Xiamen, Fujian, China

Site Status

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, China

Site Status

Countries

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China

References

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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. doi: 10.1016/j.gie.2006.10.055.

Reference Type BACKGROUND
PMID: 17591479 (View on PubMed)

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.

Reference Type RESULT
PMID: 25293825 (View on PubMed)

Other Identifiers

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20151203-5

Identifier Type: -

Identifier Source: org_study_id

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