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

ERCP Clinical Trial

Official title:

Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03350555
• Other study ID #: Additioned Endocopy in ERCP
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 20, 2017
• Start date: November 2017
• Est. completion date: December 2019

Study information

• Verified date: November 2017
• Source: Changhai Hospital
• Contact: Xiangyu Kong, MD
• Phone: 13564644397
• Email: xiaoniu185[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• People who are indicated to ERCP treatment.

Exclusion Criteria:

• People who are not suitable for ERCP treatment.

Related Conditions & MeSH terms

• ERCP

Intervention

Device:
• Additioned Endoscopy
To evaluate the use of additioned endoscopy in ERCP treatment.

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of ERCP treatment	To test if additioned endoscopy will have impact on duration of ERCP treatment	Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient
Secondary	complications of ERCP treatment	To test if additioned endoscopy will have impact on incidence of ERCP complications, including perforation, bleeding, post-ERCP pancreatitis.	up to 1 month after ERCP completion