Surgery Clinical Trial
Official title:
Effect of Preoperative Biliary Drainage on Postoperative Complications in Resectable Patients With Hilar Cholangiocarcinoma(Klatskin Tumor)
This study is to investigate whether preoperative biliary drainage can reduce the postoperative morbidity in patients with hilar cholangiocarcinoma.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
China | Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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
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 |
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