NCT03350555

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 22, 2017

Status Verified

November 1, 2017

Enrollment Period

2.1 years

First QC Date

November 10, 2017

Last Update Submit

November 20, 2017

Conditions

ERCP

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • complications of ERCP treatment

    up to 1 month after ERCP completion

Study Arms (2)

ERCP with additioned endoscopy

EXPERIMENTAL

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

Device: Additioned Endoscopy

ERCP without additioned endoscopy

NO INTERVENTION

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

Interventions

Additioned EndoscopyDEVICE

To evaluate the use of additioned endoscopy in ERCP treatment.

ERCP with additioned endoscopy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • People who are indicated to ERCP treatment.

You may not qualify if:

  • People who are not suitable for ERCP treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

Study Officials

  • Zhaoshen Li, MD

    Changhai Hospital

    STUDY CHAIR

Central Study Contacts

Xiangyu Kong, MD

CONTACT

13564644397xiaoniu185@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor of gastroenterology department

Study Record Dates

First Submitted

November 10, 2017

First Posted

November 22, 2017

Study Start

November 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 22, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)