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Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01134276
First Posted: May 31, 2010
Last Update Posted: June 11, 2014
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.
Information provided by (Responsible Party):
Sun-Whe Kim, Seoul National University Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (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 Sun-Whe Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • Incidence of Infectious Complications After Biliary Drainage [ Time Frame: within 120 days after drainage ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
Last Verified: June 2014

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


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