NCT01598142

Brief Summary

The single-operator wire-guided cannulation technique doesn't require an experienced assistant and precise coordination between the assistant and endoscopist.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
465

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
Last Updated

May 15, 2012

Status Verified

May 1, 2012

Enrollment Period

3.2 years

First QC Date

November 1, 2011

Last Update Submit

May 14, 2012

Conditions

Biliary DiseasesPancreas Diseases

Keywords

Endoscopic retrograde cholangiopancreatography (ERCP)GuidewiresCannulationSingle-operatorC-Hook

Outcome Measures

Primary Outcomes (1)

  • Cannulation success rate

    two years

Secondary Outcomes (6)

  • Incidences of post-ERCP pancreatitis

    two years

  • Incidences of bleeding

    two years

  • Incidences of perforation

    two years

  • Incidences of infection

    two years

  • Number of attempts at cannulation

    two years

  • +1 more secondary outcomes

Study Arms (2)

experienced assistant group

OTHER

experienced endoscopist with an experienced assistant.

Procedure: Team 1

new trained assistant group

OTHER

same experienced endoscopist with a new trained assistant

Procedure: Team 2

Interventions

Team 1PROCEDURE

experienced endoscopist with a experienced assistant

Also known as: experienced
experienced assistant group
Team 2PROCEDURE

same experienced endoscopist with a new trained assistant

Also known as: new trained
new trained assistant group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • hospitalized patients with pancreas and biliary diseases referred to the authors for ERCP

You may not qualify if:

  • previous endoscopic sphincterotomy,
  • surgically altered anatomy (e.g. Billroth II gastrectomy) or
  • diagnostic duodenoscopy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310003, China

Location

MeSH Terms

Conditions

Gallbladder DiseasesPancreatic Diseases

Interventions

Coping Orientation to Problems Experienced Questionnaire

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • Qi-Yong Li, MD

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

November 1, 2011

First Posted

May 15, 2012

Study Start

October 1, 2007

Primary Completion

December 1, 2010

Study Completion

February 1, 2011

Last Updated

May 15, 2012

Record last verified: 2012-05

Locations

CN(1)