Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01134276
First received: May 4, 2010
Last updated: June 7, 2014
Last verified: June 2014
Results First Received: April 7, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Periampullary Cancers With Obstructive Jaundice
Pancreas Head Cancer
Bile Duct Cancer
Ampulla of Vater Cancer
Intervention: Procedure: biliary drainage

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Total 211 patients underwent pancreatoduodenectomy after preoperative biliary drainage at Seoul National University Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
144 patients and 68 patients were intended to be treated with ERBD/ENBD and PTBD, respectively. Among 144 patients, 39 patients were switched to PTBD due to a procedure failure. Finally, 104 and 107 patients were treated with ERBD/ENBD and PTBD, respectively. Clinical outcomes were compared on the basis on the final drainage method

Reporting Groups
  Description
ERBD biliary drainage : biliary drainage via ERBD/ENBD
PTBD biliary drainage : biliary drainage via PTBD

Participant Flow:   Overall Study
    ERBD     PTBD  
STARTED     104     107  
COMPLETED     104     107  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
ERBD final biliary drainage procedure: biliary drainage via ERBD/ENBD
PTBD final biliary drainage procedure : biliary drainage via PTBD
Total Total of all reporting groups

Baseline Measures
    ERBD     PTBD     Total  
Number of Participants  
[units: participants]
  104     107     211  
Age  
[units: years]
Mean ± Standard Deviation
  66.3  ± 8.6     63.5  ± 9.0     64.8  ± 8.9  
Gender  
[units: participants]
     
Female     33     42     75  
Male     71     65     136  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     104     107     211  



  Outcome Measures
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1.  Primary:   Incidence of Infectious Complications After Biliary Drainage   [ Time Frame: within 120 days after drainage ]

2.  Secondary:   Change in Total Serum Bilirubin After Drainage   [ Time Frame: within 14 days after drainage ]

3.  Secondary:   Total Hospital Cost During Admission After Biliary Drainage   [ Time Frame: during hospital stay for biliary drainage procedure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Sun-Whe Kim
Organization: Seoul National University College of Medicine
phone: +82-2-2072-2315
e-mail: sunkim@plaza.snu.ac.kr


Publications:

Responsible Party: Sun-Whe Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01134276     History of Changes
Other Study ID Numbers: H-1001-047-307
Study First Received: May 4, 2010
Results First Received: April 7, 2014
Last Updated: June 7, 2014
Health Authority: Korea: Institutional Review Board