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Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

Primary Purpose

Cholangiocarcinoma, Drainage, Surgery

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Preoperative biliary drainage
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholangiocarcinoma focused on measuring Cholangiocarcinoma, Drainage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Preoperative biliary drainage

Controlled group

Arm Description

Outcomes

Primary Outcome Measures

Incidence of postoperative complication

Secondary Outcome Measures

Postoperative mortality
Overall survival, OS
Disease free survival, DFS

Full Information

First Posted
November 24, 2008
Last Updated
November 24, 2008
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT00797121
Brief Title
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

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
May 2008 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
May 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Drainage, Surgery
Keywords
Cholangiocarcinoma, Drainage

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative biliary drainage
Arm Type
Experimental
Arm Title
Controlled group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Preoperative biliary drainage
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of postoperative complication
Time Frame
30 days after operation
Secondary Outcome Measure Information:
Title
Postoperative mortality
Time Frame
30 days after operation
Title
Overall survival, OS
Time Frame
May, 2013
Title
Disease free survival, DFS
Time Frame
May, 2013

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lijian Liang
Phone
86-20-87755766
Ext
8096
Email
lianglj@medmail.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lijian Liang
Organizational Affiliation
Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xiaoyu Yin, MD
Organizational Affiliation
Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hepatobiliary, the first affiliated hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dong Chen, MD
Phone
86-20-87755766
Ext
8096
Email
gzbobsums2004@hotmail.com
First Name & Middle Initial & Last Name & Degree
Lijian Liang

12. IPD Sharing Statement

Citations:
PubMed Identifier
11573044
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.
Results Reference
background
PubMed Identifier
10982608
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.
Results Reference
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Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

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