Clinical trial NCT00797121: Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma
Official title: Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cholangiocarcinoma
Drainage
Surgery
Keywords: Cholangiocarcinoma
Drainage
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2008-11-25
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
measure: Incidence of postoperative complication
timeFrame: 30 days after operation
Secondary outcomes:
measure: Postoperative mortality
timeFrame: 30 days after operation
measure: Overall survival, OS
timeFrame: May, 2013
measure: Disease free survival, DFS
timeFrame: May, 2013
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen University
name: Lijian Liang
role: STUDY_CHAIR
affiliation: Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
name: Xiaoyu Yin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1097/00000658-200110000-00010.
citation: 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. doi: 10.1007/s005340050170.