Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00797121

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Study Design

Study Type:

Interventional

Anticipated 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 1, 2008

Anticipated Primary Completion Date :

May 1, 2011

Anticipated Study Completion Date :

May 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Incidence of postoperative complication [30 days after operation]

Secondary Outcome Measures

Postoperative mortality [30 days after operation]
Overall survival, OS [May, 2013]
Disease free survival, DFS [May, 2013]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510080

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