Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)
NCT ID: NCT00270868
Last Updated: 2006-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1050 participants
INTERVENTIONAL
2004-11-30
2006-11-30
Brief Summary
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Detailed Description
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We are conducting a controlled prospective multicentre randomized study to compare the double guide wire technique with the conventional method in two groups previously randomized after presenting a difficult selective biliary cannulation under the conventional method. The study is carried out in six public Hospitals from Spain. Assignation is concealed to both groups, and the expected study period is 18 months for a number of randomized patients equal or over 262 (statistical power of 90% with an α-error of 0.05, to detect a success rate of 74% in the group undergoing double guide wire technique against a success rate of 60% in the control group). The main outcome variables are successful selective biliary cannulation (primary outcome variable), number of attempts and morbimortality associated in both groups (secondary outcome variables).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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Double guide wire technique
Standard bile duct cannulation
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Carlos III Health Institute
OTHER_GOV
Puerta de Hierro University Hospital
OTHER
Principal Investigators
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Luis E Abreu, MD
Role: PRINCIPAL_INVESTIGATOR
Puerta de Hierro University Hospital. Madrid Health Service, Spain
Locations
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León Hospital
León, León, Spain
Alcorcón Hospital Foundation
Alcorcón, Madrid, Spain
Puerta de Hierro University Hospital
Madrid, Madrid, Spain
Navarra Hospital
Pamplona, Navarre, Spain
Central Hospital of Asturias
Oviedo, Principality of Asturias, Spain
La Fe University Hospital
Valencia, Valencia, Spain
Countries
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References
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Classen M, Demling L. [Endoscopic sphincterotomy of the papilla of vater and extraction of stones from the choledochal duct (author's transl)]. Dtsch Med Wochenschr. 1974 Mar 15;99(11):496-7. doi: 10.1055/s-0028-1107790. No abstract available. German.
Cotton PB, Chung SC, Davis WZ, Gibson RM, Ransohoff DF, Strasberg SM. Issues in cholecystectomy and management of duct stones. Am J Gastroenterol. 1994 Aug;89(8 Suppl):S169-76. No abstract available.
Ballinger AB, McHugh M, Catnach SM, Alstead EM, Clark ML. Symptom relief and quality of life after stenting for malignant bile duct obstruction. Gut. 1994 Apr;35(4):467-70. doi: 10.1136/gut.35.4.467.
Sherman S, Lehman GA. Endoscopic therapy of pancreatic disease. Gastroenterologist. 1997 Dec;5(4):262-77.
Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
Freeman ML. Adverse outcomes of endoscopic retrograde cholangiopancreatography. Rev Gastroenterol Disord. 2002 Fall;2(4):147-68.
Freeman ML, Nelson DB, Sherman S, Haber GB, Herman ME, Dorsher PJ, Moore JP, Fennerty MB, Ryan ME, Shaw MJ, Lande JD, Pheley AM. Complications of endoscopic biliary sphincterotomy. N Engl J Med. 1996 Sep 26;335(13):909-18. doi: 10.1056/NEJM199609263351301.
Freeman ML, DiSario JA, Nelson DB, Fennerty MB, Lee JG, Bjorkman DJ, Overby CS, Aas J, Ryan ME, Bochna GS, Shaw MJ, Snady HW, Erickson RV, Moore JP, Roel JP. Risk factors for post-ERCP pancreatitis: a prospective, multicenter study. Gastrointest Endosc. 2001 Oct;54(4):425-34. doi: 10.1067/mge.2001.117550.
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. doi: 10.1016/s0016-5107(98)70121-x.
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. doi: 10.1067/mge.2002.129086.
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. doi: 10.1111/j.1572-0241.2001.03594.x.
Masci E, Mariani A, Curioni S, Testoni PA. Risk factors for pancreatitis following endoscopic retrograde cholangiopancreatography: a meta-analysis. Endoscopy. 2003 Oct;35(10):830-4. doi: 10.1055/s-2003-42614.
Friedland S, Soetikno RM, Vandervoort J, Montes H, Tham T, Carr-Locke DL. Bedside scoring system to predict the risk of developing pancreatitis following ERCP. Endoscopy. 2002 Jun;34(6):483-8. doi: 10.1055/s-2002-32004.
Slivka A. A new technique to assist in bile duct cannulation. Gastrointest Endosc. 1996 Nov;44(5):636. doi: 10.1016/s0016-5107(96)70038-x. No abstract available.
Dumonceau JM, Deviere J, Cremer M. A new method of achieving deep cannulation of the common bile duct during endoscopic retrograde cholangiopancreatography. Endoscopy. 1998 Sep;30(7):S80. doi: 10.1055/s-2007-1001379. No abstract available.
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.
Other Identifiers
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PI 04/1942
Identifier Type: -
Identifier Source: org_study_id