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

May 4, 2010
June 7, 2014
August 2010
May 2013   (final data collection date for primary outcome measure)
Incidence of Infectious Complications After Biliary Drainage [ Time Frame: within 120 days after drainage ] [ Designated as safety issue: No ]
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Incidence of infectious complications after biliary drainage [ Time Frame: within 120 days after drainage ] [ Designated as safety issue: Yes ]
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Complete list of historical versions of study NCT01134276 on ClinicalTrials.gov Archive Site
  • Change in Total Serum Bilirubin After Drainage [ Time Frame: within 14 days after drainage ] [ Designated as safety issue: No ]
    Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)
  • Total Hospital Cost During Admission After Biliary Drainage [ Time Frame: during hospital stay for biliary drainage procedure ] [ Designated as safety issue: No ]
    Total hospital cost during admission after Biliary Drainage in US dollars
  • Effect of reducing serum total bilirubin after drainage [ Time Frame: within 14 days after drainage ] [ Designated as safety issue: Yes ]
  • Peritumoral inflammatory reaction after drainage [ Time Frame: within 7 days after operation ] [ Designated as safety issue: Yes ]
    Bile duct inflammation score measured with H&E staining
  • Fibrosis of the bile duct [ Time Frame: within 7 days after operation ] [ Designated as safety issue: Yes ]
    Fibrosis score measured with H&E staining
  • Difficulties in dissection around the tumor [ Time Frame: within 1 day after operation ] [ Designated as safety issue: No ]
    Degree of difficulties in dissection around the tumor tissue, which is assessed intraoperatively
Not Provided
Not Provided
 
Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice

Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Periampullary Cancers With Obstructive Jaundice
  • Pancreas Head Cancer
  • Bile Duct Cancer
  • Ampulla of Vater Cancer
Procedure: biliary drainage
biliary drainage via PTBD or ERBD/ENBD
  • Active Comparator: PTBD
    biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
    Intervention: Procedure: biliary drainage
  • Active Comparator: ERBD
    biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer
    Intervention: Procedure: biliary drainage

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
211
May 2013
May 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patient who have periampullary tumors causing obstructive jaundice
  • patient age: ≥20 and ≤85
  • resectable state of disease
  • no history of previous chemotherapy or radiotherapy
  • patients without uncontrollable severe cardiovascular, respiratory disease
  • Karnofsky performance scale ≥70
  • informed consent

Exclusion Criteria:

  • patients with distant metastasis or locally advanced disease with major vascular invasion
  • duodenal cancer
  • biliary drainage before randomization
  • previous chemotherapy or radiotherapy
  • uncontrollable active infection except cholangitis
  • severe comorbid disease (cardiac, pulmonary, cerebrovascular)
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01134276
H-1001-047-307
Yes
Sun-Whe Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Not Provided
Seoul National University Hospital
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP