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Preoperative Biliary Drainage for Resectable Hilar Cholangiocarcinoma

NCT ID: NCT00797121

Last Updated: 2008-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2013-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Cholangiocarcinoma Drainage Surgery

Keywords

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Cholangiocarcinoma Drainage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Preoperative biliary drainage

Group Type EXPERIMENTAL

Preoperative biliary drainage

Intervention Type PROCEDURE

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.

Controlled group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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the First affiliated hospital, Sun Yat-Sen University

Principal Investigators

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Lijian Liang

Role: STUDY_CHAIR

Department of hepatobiliary, the first affiliated hospital, Sun Yat-sen University

Xiaoyu Yin, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lijian Liang

Role: CONTACT

Phone: 86-20-87755766

Email: [email protected]

Facility Contacts

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Dong Chen, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 11573044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10982608 (View on PubMed)

Other Identifiers

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Cholangiocarcinoma

Identifier Type: -

Identifier Source: secondary_id

Surgery

Identifier Type: -

Identifier Source: secondary_id

Drainage

Identifier Type: -

Identifier Source: secondary_id

SUMS-5010

Identifier Type: -

Identifier Source: org_study_id