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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

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.

Condition or disease Intervention/treatment Phase
Common Bile Duct Diseases Procedure: Early Precut Procedure: Prolonged cannulation attempts Not Applicable

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").

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 375 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : January 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Arm Intervention/treatment
Active Comparator: Group A
Early Precut
Procedure: Early Precut
Early precut was performed during ERCP with difficult biliary cannulation

Active Comparator: Group B
Prolonged cannulation attempts
Procedure: Prolonged cannulation attempts
Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation




Primary Outcome Measures :
  1. Incidence of PEP [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02596646


Locations
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Italy
San Raffaele Hospital
Milan, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
San Giuseppe Moscati Hospital
Istituti Ospitalieri di Cremona
Valduce Hospital
Papa Giovanni XXIII Hospital
Cardarelli Hospital
Azienda Ospedaliera Universitaria Senese
Maresca Hospital
Investigators
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Principal Investigator: Pier Alberto Testoni, Professor San Raffaele Hospital

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Responsible Party: Testoni Pier Alberto, Professor, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT02596646     History of Changes
Other Study ID Numbers: PRECUT PRECOCE/01
First Posted: November 4, 2015    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Bile Duct Diseases
Common Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases