Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

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: NCT01134276
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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

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
ERBD biliary drainage : biliary drainage via ERBD/ENBD
PTBD biliary drainage : biliary drainage via PTBD

Participant Flow:   Overall Study
STARTED   104   107 
COMPLETED   104   107 

  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.
No text entered.

Reporting Groups
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 
Overall Participants Analyzed 
[Units: Participants]
 104   107   211 
[Units: Years]
Mean (Standard Deviation)
 66.3  (8.6)   63.5  (9.0)   64.8  (8.9) 
[Units: Participants]
Female   33   42   75 
Male   71   65   136 
Region of Enrollment 
[Units: Participants]
Korea, Republic of   104   107   211 

  Outcome Measures

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

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
No text entered.

  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: Sun-Whe Kim
Organization: Seoul National University College of Medicine
phone: +82-2-2072-2315


Responsible Party: Sun-Whe Kim, Seoul National University Hospital Identifier: NCT01134276     History of Changes
Other Study ID Numbers: H-1001-047-307
First Submitted: May 4, 2010
First Posted: May 31, 2010
Results First Submitted: April 7, 2014
Results First Posted: June 11, 2014
Last Update Posted: June 11, 2014