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Closed Suction Drainage and Natural Drainage of the Pancreatic Duct in Pancreaticojejunostomy

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00679952
First received: May 15, 2008
Last updated: April 13, 2011
Last verified: April 2011
History of Changes
Results First Received: March 13, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Pancreatic Fistula
Interventions: Procedure: closed suction drainage of pancreatic duct
Procedure: natural drainage of pancreatic duct

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Closed Suction Drainage Group closed suction drainage group (CD group)
Natural Drainage Group natural drainage group (ND group)

Participant Flow:   Overall Study
    Closed Suction Drainage Group     Natural Drainage Group  
STARTED     86     82  
COMPLETED     86     82  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Closed Suction Drainage Group closed suction drainage group (CD group)
Natural Drainage Group natural drainage group (ND group)
Total Total of all reporting groups

Baseline Measures
    Closed Suction Drainage Group     Natural Drainage Group     Total  
Number of Participants  
[units: participants]
 		  86     82     168  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     59     49     108  
>=65 years     27     33     60  
Age  
[units: years]
Mean ± Standard Deviation 		  60.7  ± 10.1     61.4  ± 11.1     61.2  ± 10.6  
Gender  
[units: participants]
 		     
Female     37     27     64  
Male     49     55     104  
Region of Enrollment  
[units: participants]
 		     
Korea, Republic of     86     82     168  



  Outcome Measures

1.  Primary:   Number of Patients With Pancreatic Fistula   [ Time Frame: postoperative 1 week ]
  Show Outcome Measure 1

2.  Secondary:   Severity of Pancreatic Fistulas   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Clinical instructor
Organization: Seoul National University College of Medicine
phone: 82-2-2072-2817
e-mail: meejookang@gmail.com


Publications:


Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00679952     History of Changes
Other Study ID Numbers: H-0612-018-191
Study First Received: May 15, 2008
Results First Received: March 13, 2011
Last Updated: April 13, 2011
Health Authority: Korea: Food and Drug Administration