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Completed

NCT Number: NCT02697149

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.

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Key information

Conditions

Endoscopic Retrograde Cholangiopancreatography , Gallstone Biliary Tract Diseases Calculi Cholecystolithiasis Cholelithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of gastroenterology, Chinese PLA 174 Hospital, Xiamen, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography

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.

standard endoscopic retrograde cholangiopancreatography

Radiation

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

Primary outcomes

  1. Success of endoscopic retrograde cholangiopancreatography

    Time frame: 6 months

    The success is defined by complete removal of common bile duct stones or placement of stents in proper position.

Secondary outcomes

  1. Overall complications

    Time frame: 6 months

    Post-endoscopic retrograde cholangiopancreatography pancreatitis, bleeding, perforation, infection of biliary tract

  2. Cannulation success rate

    Time frame: 6 months

    In patients with native papilla, cannulation success rate was defined as the proportion of subjects with successful cannulation of targeted duct

  3. ERCP procedure time

    Time frame: 6 months

    defined by the interval time between scope insertion and complete of endoscopic retrograde cholangiopancreatography

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 3, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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