NCT02232451

Brief Summary

The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2010

Longer than P75 for not_applicable

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

November 1, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 5, 2014

Completed
Last Updated

September 25, 2014

Status Verified

September 1, 2014

Enrollment Period

1.6 years

First QC Date

August 1, 2012

Last Update Submit

September 23, 2014

Conditions

Complications of Surgical and Medical Care: General Terms

Keywords

loopERCPcannulationbiliarywire

Outcome Measures

Primary Outcomes (1)

  • The evaluation of the incidence of PEP

    loop20216

Secondary Outcomes (1)

  • The evaluation of CBD percentage cannulation.

    loop20216

Study Arms (2)

ERCP with loop tip wire

EXPERIMENTAL

ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis.

Device: ERCP with loop tip wire

ERCP for cannulation

ACTIVE COMPARATOR

ERCP for cannulation of CBD with traditional technique

Device: ERCP for cannulation

Interventions

ERCP with loop tip wireDEVICE

Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation

ERCP with loop tip wire
ERCP for cannulationDEVICE

Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

ERCP for cannulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high risk patients for post-ERCP pancreatitis

You may not qualify if:

  • age \< 18 yrs
  • allergy to the contrast medium
  • previous surgery
  • neoplastic bilio-pancreatic disease
  • previous EBS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic RetrogradeCatheterization

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresTherapeuticsInvestigative Techniques

Study Officials

  • Enzo Masci, MD

    Hospital San Paolo

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Gastrointestinal Endoscopy

Study Record Dates

First Submitted

August 1, 2012

First Posted

September 5, 2014

Study Start

November 1, 2010

Primary Completion

June 1, 2012

Study Completion

August 1, 2014

Last Updated

September 25, 2014

Record last verified: 2014-09