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Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice


N/A
20 Years
85 Years
Open (Enrolling)
Both
Periampullary Cancers Causing Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer, Ampulla of Vater Cancer

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Trial Information

Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice


Inclusion Criteria:



- patient who have periampullary tumors causing obstructive jaundice

- patient age: ≥20 and ≤85

- resectable state of disease

- no history of previous chemotherapy or radiotherapy

- patients without uncontrollable severe cardiovascular, respiratory disease

- Karnofsky performance scale ≥70

- informed consent

Exclusion Criteria:

- patients with distant metastasis or locally advanced disease with major vascular
invasion

- duodenal cancer

- biliary drainage before randomization

- previous chemotherapy or radiotherapy

- uncontrollable active infection except cholangitis

- severe comorbid disease (cardiac, pulmonary, cerebrovascular)

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Incidence of infectious complications after biliary drainage

Outcome Description:

at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)

Outcome Time Frame:

within 120 days after drainage

Safety Issue:

Yes

Authority:

Korea: Institutional Review Board

Study ID:

H-1001-047-307

NCT ID:

NCT01134276

Start Date:

August 2010

Completion Date:

December 2013

Related Keywords:

  • Periampullary Cancers Causing Obstructive Jaundice
  • Pancreas Head Cancer
  • Bile Duct Cancer
  • Ampulla of Vater Cancer
  • Jaundice
  • Jaundice, Obstructive
  • Bile Duct Neoplasms
  • Head and Neck Neoplasms

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