Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00797121
• Other study ID #: SUMS-5010
• Secondary ID: Cholangiocarcino
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2008
• Last updated: November 24, 2008
• Start date: May 2008
• Est. completion date: May 2013

Study information

• Verified date: November 2008
• Source: Sun Yat-sen University
• Contact: Lijian Liang
• Phone: 86-20-87755766
• Email: lianglj[@]medmail.com.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: May 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Drainage
• Klatskin's Tumor
• Postoperative Complications
• Surgery

Intervention

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.

Locations

Country	Name	City	State
China	Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative complication		30 days after operation	Yes
Secondary	Postoperative mortality		30 days after operation	Yes
Secondary	Overall survival, OS		May, 2013	Yes
Secondary	Disease free survival, DFS		May, 2013	Yes