FindTrial
Sign In

Time of Cannulation During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire

Evaluation of the Cannulation Time During Primary ERCP With Short Guide Wire Rapid Exchange or With Long Guide Wire. Multicentre Prospective Randomized Trial

Status
Suspended
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02290769
Acronym
RELG
Enrollment
292
Registered
2014-11-14
Start date
2018-01-28
Completion date
2026-12-14
Last updated
2026-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatitis

Keywords

Guide wire cannulation ERCP, Time of cannulation, Rapid exchange guide wire, Guide wire

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.

Detailed description

In primary Endoscopic Retrograde Cholangio-Pancreatography (ERCP) cannulation is wire guided. Up to now there is no doubt about the efficacy of such a procedure. The use of long wire requires the help of another person behind primary operator. The use of short wire rapid exchange allows the primary operator to perform all the steps by himself. Time of cannulation is known to be directly associated to post ERCP pancreatitis. Aim of the study is to assess which length of guide wire allows the shorter cannulation time during primary ERCP. Post ERCP pancreatitis onset will be assessed for all patients

Interventions

DEVICEShort guide wire rapid exchange

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

DEVICELong guide wire

Use of long wire to guide the cannulation during primary ERCP

Sponsors

Niguarda Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Time of cannulation8 hours from interventionTime (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

Secondary

MeasureTime frameDescription
Incidence of post ERCP pancreatitis8 hours post ERCPIncidence of post ERCP pancreatitis

Countries

Italy

Contacts

STUDY_CHAIRFrancesco Pugliese, MD

Niguarda Ca' Granda Hospital

STUDY_CHAIREdoardo Forti, MD

Niguarda Ca' Granda Hospital

STUDY_CHAIRRaffaele Manta, MD

Niguarda Ca' Granda Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 17, 2026