Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)

NCT00270868 | Unknown

• 1 other identifier: PI 04/1942
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine if the double guide wire technique is more effective than the conventional method in those cases of difficult selective biliary cannulation in the ERCP procedures.

Conditions

Bile Duct Diseases

Keywords

Double guide wire technique; Difficult selective biliary cannulation; ERCP; Attempts of cannulation; Post-ERCP complications.

Outcome Measures

Primary Outcomes (1)

• Percentage of successful selective biliary cannulation

Secondary Outcomes (3)

• Number of attempts and time of cannulation.

• Morbimortality associated in both groups at hospital discharge and 4 weeks after ERCP procedure

• Factors associated with successful cannulation for both techniques

Interventions

Double guide wire technique PROCEDURE

Standard bile duct cannulation PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Clinical and/or radiological suspicion of Bile Duct Diseases which require ERCP procedure with intention of selective biliary cannulation
• Patients must be admitted in the participant hospitals of the investigators units
• Written informed consent of the patient, relative or legal tutor

You may not qualify if:

• Previous biliary or pancreatic sphincterotomy
• Previous pneumatic dilatation of duodenal papilla
• Presence of biliary-digestive derivation
• Previous diagnosis or suspected pancreas divisum
• Use of any biliary or pancreatic stent in the last 6 months
• Use of any drug aimed to reduce post-ERCP pancreatitis
• Pregnancy or maternal feeding

Sponsors & Collaborators

• Puerta de Hierro University Hospital: lead
• Carlos III Health Institute: collaborator

Study Sites (6)

León Hospital

León, León, 24071, Spain

Location

Alcorcón Hospital Foundation

Alcorcón, Madrid, 28922, Spain

Location

Puerta de Hierro University Hospital

Madrid, Madrid, 28035, Spain

Location

Navarra Hospital

Pamplona, Navarre, 31008, Spain

Location

Central Hospital of Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

La Fe University Hospital

Valencia, Valencia, 46009, Spain

Location

Related Publications (16)

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  PMID: 9826155 BACKGROUND

• Herreros de Tejada A, Calleja JL, Diaz G, Pertejo V, Espinel J, Cacho G, Jimenez J, Millan I, Garcia F, Abreu L; UDOGUIA-04 Group. Double-guidewire technique for difficult bile duct cannulation: a multicenter randomized, controlled trial. Gastrointest Endosc. 2009 Oct;70(4):700-9. doi: 10.1016/j.gie.2009.03.031. Epub 2009 Jun 27.

  PMID: 19560764 DERIVED

MeSH Terms

Conditions

Bile Duct Diseases

Condition Hierarchy (Ancestors)

Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Luis E Abreu, MD

  Puerta de Hierro University Hospital. Madrid Health Service, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 27, 2005
• First Posted: December 28, 2005
• Study Start: November 1, 2004
• Study Completion: November 1, 2006
• Last Updated: October 18, 2006

Record last verified: 2006-10

Locations

ES (6)