Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-27 @ 1:03 AM
Study NCT ID:
NCT00270868
Status:
UNKNOWN
Last Update Posted:
2006-10-18
First Post:
2005-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001649', 'term': 'Bile Duct Diseases'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 1050}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2004-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'completionDateStruct': {'date': '2006-11'}, 'lastUpdateSubmitDate': '2006-10-17', 'studyFirstSubmitDate': '2005-12-27', 'studyFirstSubmitQcDate': '2005-12-27', 'lastUpdatePostDateStruct': {'date': '2006-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of successful selective biliary cannulation'}], 'secondaryOutcomes': [{'measure': 'Number of attempts and time of cannulation.'}, {'measure': 'Morbimortality associated in both groups at hospital discharge and 4 weeks after ERCP procedure'}, {'measure': 'Factors associated with successful cannulation for both techniques'}]}, 'conditionsModule': {'keywords': ['Double guide wire technique', 'Difficult selective biliary cannulation', 'ERCP', 'Attempts of cannulation', 'Post-ERCP complications.'], 'conditions': ['Bile Duct Diseases']}, 'referencesModule': {'references': [{'pmid': '4835515', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '8048408', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '7513672', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9436003', 'type': 'BACKGROUND', 'citation': 'Sherman S, Lehman GA. Endoscopic therapy of pancreatic disease. Gastroenterologist. 1997 Dec;5(4):262-77.'}, {'pmid': '2070995', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12481167', 'type': 'BACKGROUND', 'citation': 'Freeman ML. Adverse outcomes of endoscopic retrograde cholangiopancreatography. Rev Gastroenterol Disord. 2002 Fall;2(4):147-68.'}, {'pmid': '8782497', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11577302', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9684657', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12397271', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11232684', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '14551860', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12048633', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '8934189', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '9826155', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '19560764', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Complications associated with ERCP have been related with certain characteristics of the procedure. One is the number of attempts of selective biliary cannulation. Our hypothesis is that double guide wire placement could be a useful technique for selective biliary cannulation in those cases of difficult ERCP procedures, reducing the number of cannulation attempts and the complication associated with the procedure.\n\nWe 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age over 18 years\n* Clinical and/or radiological suspicion of Bile Duct Diseases which require ERCP procedure with intention of selective biliary cannulation\n* Patients must be admitted in the participant hospitals of the investigators units\n* Written informed consent of the patient, relative or legal tutor\n\nExclusion Criteria:\n\n* Previous biliary or pancreatic sphincterotomy\n* Previous pneumatic dilatation of duodenal papilla\n* Presence of biliary-digestive derivation\n* Previous diagnosis or suspected pancreas divisum\n* Use of any biliary or pancreatic stent in the last 6 months\n* Use of any drug aimed to reduce post-ERCP pancreatitis\n* Pregnancy or maternal feeding\n* Previous inclusion in the study'}, 'identificationModule': {'nctId': 'NCT00270868', 'briefTitle': 'Efficacy of Double Wire Technique in Difficult Cases of Common Bile Duct Cannulation in ERCP (UDOGUIA-04)', 'organization': {'class': 'OTHER', 'fullName': 'Puerta de Hierro University Hospital'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': 'PI 04/1942'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Double guide wire technique', 'type': 'PROCEDURE'}, {'name': 'Standard bile duct cannulation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '24071', 'city': 'León', 'state': 'León', 'country': 'Spain', 'facility': 'León Hospital', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'zip': '28922', 'city': 'Alcorcón', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Alcorcón Hospital Foundation', 'geoPoint': {'lat': 40.34582, 'lon': -3.82487}}, {'zip': '28035', 'city': 'Madrid', 'state': 'Madrid', 'country': 'Spain', 'facility': 'Puerta de Hierro University Hospital', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'state': 'Navarre', 'country': 'Spain', 'facility': 'Navarra Hospital', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': '33006', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Central Hospital of Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}, {'zip': '46009', 'city': 'Valencia', 'state': 'Valencia', 'country': 'Spain', 'facility': 'La Fe University Hospital', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Luis E Abreu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Puerta de Hierro University Hospital. Madrid Health Service, Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Puerta de Hierro University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Carlos III Health Institute', 'class': 'OTHER_GOV'}]}}}