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Clinical Trials to Validate the Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography

Not Applicable
Conditions
ERCP
Interventions
Device: Additioned Endoscopy
Registration Number
NCT03350555
Lead Sponsor
Changhai Hospital
Brief Summary

Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.

Detailed Description

Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
Inclusion Criteria
  • People who are indicated to ERCP treatment.
Exclusion Criteria
  • People who are not suitable for ERCP treatment.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ERCP with additioned endoscopyAdditioned EndoscopyThis arm will include participants undergoing ERCP with assistance of additioned endoscopy.
Primary Outcome Measures
NameTimeMethod
Duration of ERCP treatmentDuration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient

To test if additioned endoscopy will have impact on duration of ERCP treatment

Secondary Outcome Measures
NameTimeMethod
complications of ERCP treatmentup to 1 month after ERCP completion

To test if additioned endoscopy will have impact on incidence of ERCP complications, including perforation, bleeding, post-ERCP pancreatitis.

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University

🇨🇳

Shanghai, Shanghai, China

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