Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma - Full Text View

Sponsored by:	Sun Yat-sen University
Information provided by:	Sun Yat-sen University
ClinicalTrials.gov Identifier:	NCT00797121

Purpose

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

Condition	Intervention	Phase
Cholangiocarcinoma Drainage Surgery	Procedure: Preoperative biliary drainage	Phase IV

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:

Incidence of postoperative complication [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Postoperative mortality [ Time Frame: 30 days after operation ] [ Designated as safety issue: Yes ]
Overall survival, OS [ Time Frame: May, 2013 ] [ Designated as safety issue: Yes ]
Disease free survival, DFS [ Time Frame: May, 2013 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	82
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Preoperative biliary drainage: Experimental	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.
Controlled group: No Intervention

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797121

Contacts

Contact: Lijian Liang

86-20-87755766 ext 8096

lianglj@medmail.com.cn

Locations

China, Guangdong Province
Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University	Recruiting
Guangzhou, Guangdong Province, China, 510080
Contact: Dong Chen, MD 86-20-87755766 ext 8096 gzbobsums2004@hotmail.com
Principal Investigator: Lijian Liang

Sponsors and Collaborators

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

More Information

Publications:

Jarnagin WR, Fong Y, DeMatteo RP, Gonen M, Burke EC, Bodniewicz BS J, Youssef BA M, Klimstra D, Blumgart LH. Staging, resectability, and outcome in 225 patients with hilar cholangiocarcinoma. Ann Surg. 2001 Oct;234(4):507-17; discussion 517-9.

Nimura Y, Kamiya J, Kondo S, Nagino M, Uesaka K, Oda K, Sano T, Yamamoto H, Hayakawa N. Aggressive preoperative management and extended surgery for hilar cholangiocarcinoma: Nagoya experience. J Hepatobiliary Pancreat Surg. 2000;7(2):155-62.

Responsible Party:	the First affiliated hospital, Sun Yat-Sen University ( Liang Li-jian )
Study ID Numbers:	SUMS-5010, Cholangiocarcinoma, Surgery, Drainage
Study First Received:	November 24, 2008
Last Updated:	November 24, 2008
ClinicalTrials.gov Identifier:	NCT00797121
Health Authority:	China: Ministry of Health

Keywords provided by Sun Yat-sen University:

Cholangiocarcinoma
Drainage

Study placed in the following topic categories:

Cholangiocarcinoma
Postoperative Complications
Klatskin tumor
Bilirubin

Adenocarcinoma
Neoplasms, Glandular and Epithelial
Carcinoma
Klatskin's Tumor

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009