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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00679952
Recruitment Status : Completed
First Posted : May 19, 2008
Results First Posted : May 9, 2011
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
Seoul National University Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Pancreatic Fistula
Interventions: Procedure: closed suction drainage of pancreatic duct
Procedure: natural drainage of pancreatic duct

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
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 

  Baseline Characteristics

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
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 
Overall Participants Analyzed 
[Units: Participants]
 86   82   168 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   59   49   108 
>=65 years   27   33   60 
[Units: Years]
Mean (Standard Deviation)
 60.7  (10.1)   61.4  (11.1)   61.2  (10.6) 
[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 ]

2.  Secondary:   Severity of Pancreatic Fistulas   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

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: Clinical instructor
Organization: Seoul National University College of Medicine
phone: 82-2-2072-2817


Responsible Party: Seoul National University Hospital Identifier: NCT00679952     History of Changes
Other Study ID Numbers: H-0612-018-191
First Submitted: May 15, 2008
First Posted: May 19, 2008
Results First Submitted: March 13, 2011
Results First Posted: May 9, 2011
Last Update Posted: May 19, 2014