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

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00270868
• Other study ID #: PI 04/1942
• Status: Active, not recruiting
• Phase: N/A
• First received: December 27, 2005
• Last updated: October 17, 2006
• Start date: November 2004
• Est. completion date: November 2006

Study information

• 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

Clinical Trial 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.

Description:

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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1050
• Est. completion date: November 2006
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bile Duct Diseases

Intervention

Procedure:
• Double guide wire technique

• Standard bile duct cannulation

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Puerta de Hierro University Hospital	Carlos III Health Institute

Country where clinical trial is conducted

Spain, 

References & Publications (15)

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. — View 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. German. — View 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. Review. — View 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. Review. — View Citation

Dumonceau JM, Devière 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. — View 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. — View 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. — View Citation

Freeman ML. Adverse outcomes of endoscopic retrograde cholangiopancreatography. Rev Gastroenterol Disord. 2002 Fall;2(4):147-68. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Sherman S, Lehman GA. Endoscopic therapy of pancreatic disease. Gastroenterologist. 1997 Dec;5(4):262-77. Review. — View Citation

Slivka A. A new technique to assist in bile duct cannulation. Gastrointest Endosc. 1996 Nov;44(5):636. — View 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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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