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Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01134276
First received: May 4, 2010
Last updated: April 3, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention
Periampullary Cancers Causing Obstructive Jaundice
Pancreas Head Cancer
Bile Duct Cancer
Ampulla of Vater Cancer
 Procedure: biliary drainage

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 149
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTBD Procedure: biliary drainage
biliary drainage via PTBD or ERBD
Active Comparator: ERBD Procedure: biliary drainage
biliary drainage via PTBD or ERBD

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134276

Contacts
Contact: Sun-Whe Kim, M.D., Ph. D. 82-2-2072-2310 sunkim@plaza.snu.ac.kr
Contact: Ye Rim Chang, M.D. 82-2-2072-1959 yerimchang@gmail.com

Locations
Korea, Republic of
Department of Surgery, Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Sun-Whe Kim, M.D., Ph.D.     82-2-2072-2310     sunkim@plaza.snu.ac.kr    
Contact: Ye Rim Chang, M.D.     82-2-2072-1959     yerimchang@gmail.com    
Principal Investigator: Sun-Whe Kim, M.D., Ph.D.            
Principal Investigator: Jin-Young Jang, M.D., Ph.D.            
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Publications:

Responsible Party: Sun-Whe Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01134276     History of Changes
Other Study ID Numbers: H-1001-047-307
Study First Received: May 4, 2010
Last Updated: April 3, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Jaundice
Jaundice, Obstructive
Bile Duct Neoplasms
Head and Neck Neoplasms
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms
 Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013