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Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

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. Identifier: NCT00797121
Recruitment Status : Unknown
Verified November 2008 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 25, 2008
Last Update Posted : November 25, 2008
Information provided by:
Sun Yat-sen University

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

Condition or disease Intervention/treatment Phase
Cholangiocarcinoma Drainage Surgery Procedure: Preoperative biliary drainage Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)
Study Start Date : May 2008
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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

Primary Outcome Measures :
  1. Incidence of postoperative complication [ Time Frame: 30 days after operation ]

Secondary Outcome Measures :
  1. Postoperative mortality [ Time Frame: 30 days after operation ]
  2. Overall survival, OS [ Time Frame: May, 2013 ]
  3. Disease free survival, DFS [ Time Frame: May, 2013 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00797121

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Contact: Lijian Liang 86-20-87755766 ext 8096

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China, Guangdong
Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Dong Chen, MD    86-20-87755766 ext 8096   
Principal Investigator: Lijian Liang         
Sponsors and Collaborators
Sun Yat-sen University
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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
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Responsible Party: Liang Li-jian, the First affiliated hospital, Sun Yat-Sen University Identifier: NCT00797121    
Other Study ID Numbers: SUMS-5010
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: November 25, 2008
Last Verified: November 2008
Keywords provided by Sun Yat-sen University:
Additional relevant MeSH terms:
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Klatskin Tumor
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type