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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
  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 With Obstructive Jaundice
Pancreas Head Cancer
Bile Duct Cancer
Ampulla of Vater Cancer
Procedure: biliary drainage

Study Type: Interventional
Study Design: Allocation: Non-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:


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: No ]
    at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)


Secondary Outcome Measures:
  • 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


Enrollment: 211
Study Start Date: August 2010
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PTBD
biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
Procedure: biliary drainage
biliary drainage via PTBD or ERBD/ENBD
Active Comparator: ERBD
biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer
Procedure: biliary drainage
biliary drainage via PTBD or ERBD/ENBD

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134276

Locations
Korea, Republic of
Department of Surgery, Seoul National University Hospital
Seoul, Korea, Republic of
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
Results First Received: April 7, 2014
Last Updated: June 7, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Jaundice
Jaundice, Obstructive
Hyperbilirubinemia
Pathologic Processes
Signs and Symptoms
Skin Manifestations

ClinicalTrials.gov processed this record on November 24, 2014