NCT02290769

Brief Summary

The aim of this study is to compare the cannulation time during primary wire guided ERCP (Endoscopic Retrograde Cholangio-Pancreatography) according to two different length of guide wire: long wire or short wire rapid exchange, artery by a prospective randomized trial.

Trial Health

53
Monitor

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
suspended

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 Progress94%
Jan 2018Dec 2026

First Submitted

Initial submission to the registry

October 27, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 14, 2014

Completed
3.2 years until next milestone

Study Start

First participant enrolled

January 28, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2018

Completed
8.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2026

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

Same day

First QC Date

October 27, 2014

Last Update Submit

April 13, 2026

Conditions

Pancreatitis

Keywords

Guide wire cannulation ERCPTime of cannulationRapid exchange guide wireGuide wire

Outcome Measures

Primary Outcomes (1)

  • Time of cannulation

    Time (in seconds) required to perform a complete and successful deep cannulation of the "biliary papilla" and the biliary tree assessed by timing it and reporting it in the prefashioned database

    8 hours from intervention

Secondary Outcomes (1)

  • Incidence of post ERCP pancreatitis

    8 hours post ERCP

Study Arms (2)

Short guide wire rapid exchange

EXPERIMENTAL

Use of short guide wire rapid exchange to guide the cannulation during primary ERCP

Device: Short guide wire rapid exchange

Long guide wire

ACTIVE COMPARATOR

Use of long wire to guide the cannulation during primary ERCP

Device: Long guide wire

Interventions

Long guide wireDEVICE

Use of long wire to guide the cannulation during primary ERCP

Long guide wire
Short guide wire rapid exchangeDEVICE

Use of short guide wire rapid exchange to guide the cannulation during primary ERCP

Short guide wire rapid exchange

Eligibility Criteria

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

You may qualify if:

  • indication to primary ERCP
  • ASA (American Society of Anesthesiologists) 1, 2, 3

You may not qualify if:

  • pancreas neoplasia
  • pancreatitis
  • ampulloma
  • duodenum stenosis
  • under mucous membrane haematoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niguarda Hospital

Milan, 20100, Italy

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Francesco Pugliese, MD

    Niguarda Ca' Granda Hospital

    STUDY CHAIR

  • Edoardo Forti, MD

    Niguarda Ca' Granda Hospital

    STUDY CHAIR

  • Raffaele Manta, MD

    Niguarda Ca' Granda Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 14, 2014

Study Start

January 28, 2018

Primary Completion

January 28, 2018

Study Completion (Estimated)

December 14, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Locations

IT(1)