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Bile Duct DiseasesNCT00270868

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

A study testing Double guide wire technique and Standard bile duct cannulation in people with Bile Duct Diseases, run by Puerta de Hierro University Hospital at 6 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bile Duct Diseases
What is being tested?
Double guide wire technique and Standard bile duct cannulation
Type of treatment
Surgery or procedure
How many people
1,050 participants
Where
6 sitesSpain
Study dates
Nov 2004to Nov 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Spain6 sites

  • Alcorcón Hospital Foundation

    Alcorcón, Madrid, 28922

  • León Hospital

    León, León, 24071

  • Puerta de Hierro University Hospital

    Madrid, Madrid, 28035

  • Central Hospital of Asturias

    Oviedo, Principality of Asturias, 33006

  • Navarra Hospital

    Pamplona, Navarre, 31008

  • La Fe University Hospital

    Valencia, Valencia, 46009

Other trials in Spain

About this study

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.

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.

Read the detailed 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).

Being tested
Double guide wire technique, Standard bile duct cannulation
Keywords
Double guide wire technique, Difficult selective biliary cannulation, ERCP, Attempts of cannulation, Post-ERCP complications.
Medical subject headings
Bile Duct Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double guide wire techniqueProcedure or surgery

  • Standard bile duct cannulationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of successful selective biliary cannulation

Secondary outcomes (3)

  1. Number of attempts and time of cannulation.

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

  3. Factors associated with successful cannulation for both techniques

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2005 (estimated)
  2. Study startNov 2004
  3. Study completionNov 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
1,050 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00270868
Sponsor's protocol ID
PI 04/1942
Status last verified
Oct 2006
First submitted
27 Dec 2005
Last updated
18 Oct 2006
Results posted
No

Publications

  • 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.

    PubMed 4835515

  • 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.

    PubMed 8048408

  • 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.

    PubMed 7513672

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

    PubMed 9436003

  • 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.

    PubMed 2070995

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

    PubMed 12481167

  • 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.

    PubMed 8782497

  • 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.

    PubMed 11577302

  • 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.

    PubMed 9684657

  • 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.

    PubMed 12397271

  • 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.

    PubMed 11232684

  • 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.

    PubMed 14551860

  • 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.

    PubMed 12048633

  • 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.

    PubMed 8934189

  • 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.

    PubMed 9826155

Questions about this trial

What is this clinical trial studying?

A study testing Double guide wire technique and Standard bile duct cannulation in people with Bile Duct Diseases, run by Puerta de Hierro University Hospital at 6 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of successful selective biliary cannulation. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00270868, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2006.

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