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Early Precut in Difficult Biliary Cannulation

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ClinicalTrials.gov Identifier: NCT02596646
Recruitment Status : Terminated (Interim analysis recommended terminating the study)
First Posted : November 4, 2015
Last Update Posted : November 6, 2015
Sponsor:
Collaborators:
San Giuseppe Moscati Hospital
Istituti Ospitalieri di Cremona
Valduce Hospital
Papa Giovanni XXIII Hospital
Cardarelli Hospital
Azienda Ospedaliera Universitaria Senese
Maresca Hospital
Information provided by (Responsible Party):
Testoni Pier Alberto, Università Vita-Salute San Raffaele

Tracking Information
First Submitted Date  ICMJE September 7, 2015
First Posted Date  ICMJE November 4, 2015
Last Update Posted Date November 6, 2015
Study Start Date  ICMJE January 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
Incidence of PEP [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2015)
Incidence of overall complications [ Time Frame: 24 hours ]
The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2015)
Incidence of overall complications [ Time Frame: 24 hours ]
We recorded the incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP, defined according to the protocol
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Precut in Difficult Biliary Cannulation
Official Title  ICMJE Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)
Brief Summary This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.
Detailed Description In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Common Bile Duct Diseases
Intervention  ICMJE
  • Procedure: Early Precut
    Early precut was performed during ERCP with difficult biliary cannulation
  • Procedure: Prolonged cannulation attempts
    Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation
Study Arms  ICMJE
  • Active Comparator: Group A
    Early Precut
    Intervention: Procedure: Early Precut
  • Active Comparator: Group B
    Prolonged cannulation attempts
    Intervention: Procedure: Prolonged cannulation attempts
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: November 3, 2015)
375
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP.

Exclusion Criteria:

  • active cholangitis or pancreatitis
  • chronic pancreatitis,
  • previous sphincterotomy,
  • prior gastric surgery,
  • coagulopathy,
  • severe comorbidity (need for tracheal intubation)
  • patients who refused or were unable to give informed consent.
  • patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"),
  • detection of ampulloma or peri-papillary diverticula during ERCP.
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02596646
Other Study ID Numbers  ICMJE PRECUT PRECOCE/01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Testoni Pier Alberto, Università Vita-Salute San Raffaele
Study Sponsor  ICMJE Università Vita-Salute San Raffaele
Collaborators  ICMJE
  • San Giuseppe Moscati Hospital
  • Istituti Ospitalieri di Cremona
  • Valduce Hospital
  • Papa Giovanni XXIII Hospital
  • Cardarelli Hospital
  • Azienda Ospedaliera Universitaria Senese
  • Maresca Hospital
Investigators  ICMJE
Principal Investigator: Pier Alberto Testoni, Professor San Raffaele Hospital
PRS Account Università Vita-Salute San Raffaele
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP