Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

June 7, 2014 updated by: Sun-Whe Kim, Seoul National University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

211

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Surgery, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 120 days after drainage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within 14 days after drainage
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
during hospital stay for biliary drainage procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (ESTIMATE)

May 31, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 7, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1001-047-307

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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