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

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.

Study Overview

• Status: Completed
• Conditions: Endoscopic Retrograde Cholangiopancreatography , Gallstone
• Intervention / Treatment: Radiation: nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography; Radiation: standard endoscopic retrograde cholangiopancreatography

• Study Type: Observational
• Enrollment (Actual): 219

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361001
      • Department of gastroenterology, Chinese PLA 174 Hospital
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital of Digestive Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

18-90 years old, patients undergoing endoscopic retrograde cholangiopancreatography

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: December 17, 2015
• First Submitted That Met QC Criteria: February 28, 2016
• First Posted (Estimate): March 3, 2016

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: ERCP; nonradiation-to-endoscopist; gallstones
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: 20151203-5