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Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

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ClinicalTrials.gov Identifier: NCT01134276
Recruitment Status : Completed
First Posted : May 31, 2010
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
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
Enrollment 211
Recruitment Details Total 211 patients underwent pancreatoduodenectomy after preoperative biliary drainage at Seoul National University Hospital.
Pre-assignment Details 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
Arm/Group Title ERBD PTBD
Hide Arm/Group Description biliary drainage : biliary drainage via ERBD/ENBD biliary drainage : biliary drainage via PTBD
Period Title: Overall Study
Started 104 107
Completed 104 107
Not Completed 0 0
Arm/Group Title ERBD PTBD Total
Hide Arm/Group Description final biliary drainage procedure: biliary drainage via ERBD/ENBD final biliary drainage procedure : biliary drainage via PTBD Total of all reporting groups
Overall Number of Baseline Participants 104 107 211
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 104 participants 107 participants 211 participants
66.3  (8.6) 63.5  (9.0) 64.8  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 104 participants 107 participants 211 participants
Female
33
  31.7%
42
  39.3%
75
  35.5%
Male
71
  68.3%
65
  60.7%
136
  64.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 104 participants 107 participants 211 participants
104 107 211
1.Primary Outcome
Title Incidence of Infectious Complications After Biliary Drainage
Hide Description at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Time Frame within 120 days after drainage
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTBD ERBD
Hide Arm/Group Description:
finial biliary drainage procedure: biliary drainage via PTBD
finial biliary drainage procedure: biliary drainage via ERBD or ENBD
Overall Number of Participants Analyzed 107 104
Measure Type: Number
Unit of Measure: participants
11 5
2.Secondary Outcome
Title Change in Total Serum Bilirubin After Drainage
Hide Description Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)
Time Frame within 14 days after drainage
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTBD ENBD/ERBD
Hide Arm/Group Description:
Final biliary drainage procedure: biliary drainage via PTBD
Final biliary drainage procedure: biliary drainage via ENBD/ERBD
Overall Number of Participants Analyzed 107 104
Mean (Standard Deviation)
Unit of Measure: mg/dL/day
0.7  (0.5) 0.6  (0.4)
3.Secondary Outcome
Title Total Hospital Cost During Admission After Biliary Drainage
Hide Description Total hospital cost during admission after Biliary Drainage in US dollars
Time Frame during hospital stay for biliary drainage procedure
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title PTBD ERBD
Hide Arm/Group Description:
Final biliary drainage procedure: biliary drainage via PTBD
Final biliary drainage procedure: biliary drainage via ERBD/ENBD
Overall Number of Participants Analyzed 107 104
Mean (Standard Deviation)
Unit of Measure: thousands in US dollars
16.0  (5.9) 17.0  (7.5)
Time Frame 7 days after procedure such as PTBD and ENBD/ERBD per Intervention
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title PTBD ERBD
Hide Arm/Group Description

final biliary drainage procedure: biliary drainage via PTBD

Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting

final biliary drainage procedure: biliary drainage via ERBD/ENBD

Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting

All-Cause Mortality
PTBD ERBD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
PTBD ERBD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   29/107 (27.10%)      23/104 (22.12%)    
Blood and lymphatic system disorders     
Bleeding  [1]  6/107 (5.61%)  6 3/104 (2.88%)  3
Gastrointestinal disorders     
Pancreatitis  [2]  3/107 (2.80%)  3 17/104 (16.35%)  17
Cholangitis  [3]  9/107 (8.41%)  9 5/104 (4.81%)  5
Bile peritonitis  [4]  2/107 (1.87%)  2 0/104 (0.00%)  0
Surgical and medical procedures     
tube malfunction  [5]  9/107 (8.41%)  9 7/104 (6.73%)  7
Indicates events were collected by systematic assessment
[1]
procedure associated bleeding event after PTBD or ENBD/ERBD
[2]
Procedure associated pancreatitis after PTBD and ENBD/ERBD
[3]
Procedure associated cholangitis after PTBD and ENBD/ERBD
[4]
Procedure associated peritonitis
[5]
tube malfunction which should be managed with additional procedure after PTBD and ENBD/ERBD
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
PTBD ERBD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/107 (0.00%)      0/104 (0.00%)    
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
ClinicalTrials.gov 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