Bile Duct Diseases Clinical Trial
Official title:
Double Guide Wire Placement Compared With Conventional Method in Cases of Difficult Common Bile Duct Cannulation in Endoscopic Retrograde Cholangiopancreatography Procedures. A Controlled Multicentred Randomized Trial.
Verified date | October 2006 |
Source | Puerta de Hierro University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 1050 |
Est. completion date | November 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - Previous inclusion in the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Alcorcón Hospital Foundation | Alcorcón | Madrid |
Spain | León Hospital | Leon | León |
Spain | Puerta de Hierro University Hospital | Madrid | |
Spain | Central Hospital of Asturias | Oviedo | Asturias |
Spain | Navarra Hospital | Pamplona | Navarra |
Spain | La Fe University Hospital | Valencia |
Lead Sponsor | Collaborator |
---|---|
Puerta de Hierro University Hospital | Carlos III Health Institute |
Spain,
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Loperfido S, Angelini G, Benedetti G, Chilovi F, Costan F, De Berardinis F, De Bernardin M, Ederle A, Fina P, Fratton A. Major early complications from diagnostic and therapeutic ERCP: a prospective multicenter study. Gastrointest Endosc. 1998 Jul;48(1):1-10. — View Citation
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Masci E, Toti G, Mariani A, Curioni S, Lomazzi A, Dinelli M, Minoli G, Crosta C, Comin U, Fertitta A, Prada A, Passoni GR, Testoni PA. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol. 2001 Feb;96(2):417-23. — View Citation
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Vandervoort J, Soetikno RM, Tham TC, Wong RC, Ferrari AP Jr, Montes H, Roston AD, Slivka A, Lichtenstein DR, Ruymann FW, Van Dam J, Hughes M, Carr-Locke DL. Risk factors for complications after performance of ERCP. Gastrointest Endosc. 2002 Nov;56(5):652-6. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of successful selective biliary cannulation | |||
Secondary | Number of attempts and time of cannulation. | |||
Secondary | Morbimortality associated in both groups at hospital discharge and 4 weeks after ERCP procedure | |||
Secondary | Factors associated with successful cannulation for both techniques |
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