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

Sponsor
Changhai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03350555
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Additioned Endoscopy
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
One arm includes participants who will receive additioned endoscopy assisted ERCP, and the other arm includes participants who will not receive additioned endoscopy assisted ERCP.One arm includes participants who will receive additioned endoscopy assisted ERCP, and the other arm includes participants who will not receive additioned endoscopy assisted ERCP.
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography
Anticipated Study Start Date :
Nov 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: ERCP with additioned endoscopy

This arm will include participants undergoing ERCP with assistance of additioned endoscopy.

Device: Additioned Endoscopy
To evaluate the use of additioned endoscopy in ERCP treatment.
No Intervention: ERCP without additioned endoscopy

This arm will include participants undergoing ERCP without assistance of additioned endoscopy as negative controls.

Outcome Measures

Primary Outcome Measures

  1. Duration of ERCP treatment [Duration 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

  1. complications of ERCP treatment [up 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • People who are indicated to ERCP treatment.
Exclusion Criteria:
  • People who are not suitable for ERCP treatment.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhai Hospital, Second Military Medical University Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

  • Study Chair: Zhaoshen Li, MD, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiangyu Kong, Doctor of gastroenterology department, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT03350555
Other Study ID Numbers:
  • Additioned Endocopy in ERCP
First Posted:
Nov 22, 2017
Last Update Posted:
Nov 22, 2017
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 22, 2017