Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

November 24, 2008 updated by: Sun Yat-sen University

Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)

This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Preoperative biliary drainage(PBD) or not, is a Hot Spot issue in the management of Hilar cholangiocarcinoma. Surgeons from Japan tend to perform PTBD(Percutaneous Transhepatic Biliary Drainage) before a definite operation until the total bilirubin(TB) lower than 85μmol/L. For some patients needed to perform extended curative resection, PVE(Portal Vein Embolization) is performed and thus the duration of PBD may be around six weeks and the final TB is lower than 34μmol/L. Some tend to perform a definite curative operation in a short time after diagnosis. There is no RCT research on the effect of PBD for the resectable Hilar Cholangiocarcinoma patients to date.

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Phase 4

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

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Lijian Liang

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients newly diagnosed
  • Resectable patients after imaging assessment and evaluation of general condition of the patient
  • TB>85μmol/L
  • WBC account more than 1.5×109/L, PLT account more than 100×109/L and HB account more than 100g/L
  • No serious disease in heart, lung and kidney
  • Written informed consent

Exclusion Criteria:

  • Unresectable patients.
  • Patients have received biliary drainage procedure such as PTBD before admission
  • Complicated with chronic hepatitis
  • Myocardia infarction record within six months
  • Women in pregnancy
  • Serious disease in heart, lung or kidney

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preoperative biliary drainage
Procedure: Preoperative biliary drainage
Percutaneous transhepatic biliary drainage(PTBD) is performed under the guidance of ultrasound. The duration may be around four weeks to make the total bilirubin of patients lower than 85μmol/L.
No Intervention: Controlled group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of postoperative complication
Time Frame: 30 days after operation
30 days after operation

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative mortality
Time Frame: 30 days after operation
30 days after operation
Overall survival, OS
Time Frame: May, 2013
May, 2013
Disease free survival, DFS
Time Frame: May, 2013
May, 2013

Collaborators and Investigators

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

Sponsor

Sun Yat-sen University

Investigators

  • Study Chair: Lijian Liang, Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
  • Principal Investigator: Xiaoyu Yin, MD, Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University

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

May 1, 2008

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

May 1, 2013

Study Registration Dates

First Submitted

November 24, 2008

First Submitted That Met QC Criteria

November 24, 2008

First Posted (Estimate)

November 25, 2008

Study Record Updates

Last Update Posted (Estimate)

November 25, 2008

Last Update Submitted That Met QC Criteria

November 24, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SUMS-5010
  • cholangiocarcinoma
  • Surgery
  • DRAINAGE

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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