Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
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ClinicalTrials.gov Identifier: NCT01134276 |
Recruitment Status :
Completed
First Posted : May 31, 2010
Results First Posted : June 11, 2014
Last Update Posted : June 11, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Periampullary Cancers With Obstructive Jaundice Pancreas Head Cancer Bile Duct Cancer Ampulla of Vater Cancer | Procedure: biliary drainage | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 211 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prospective Study on the Comparison Between the Clinicopathological Outcomes According to the Methods of Preoperative Biliary Drainage in Periampullary Cancers Causing Obstructive Jaundice |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | May 2013 |
Actual Study Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: PTBD
biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
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Procedure: biliary drainage
biliary drainage via PTBD or ERBD/ENBD |
Active Comparator: ERBD
biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer
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Procedure: biliary drainage
biliary drainage via PTBD or ERBD/ENBD |
- Incidence of Infectious Complications After Biliary Drainage [ Time Frame: within 120 days after drainage ]at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
- Change in Total Serum Bilirubin After Drainage [ Time Frame: within 14 days after drainage ]Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)
- Total Hospital Cost During Admission After Biliary Drainage [ Time Frame: during hospital stay for biliary drainage procedure ]Total hospital cost during admission after Biliary Drainage in US dollars

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Ages Eligible for Study: | 20 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134276
Korea, Republic of | |
Department of Surgery, Seoul National University Hospital | |
Seoul, Korea, Republic of |
Publications:
Responsible Party: | Sun-Whe Kim, Professor, Seoul National University Hospital |
ClinicalTrials.gov Identifier: | NCT01134276 History of Changes |
Other Study ID Numbers: |
H-1001-047-307 |
First Posted: | May 31, 2010 Key Record Dates |
Results First Posted: | June 11, 2014 |
Last Update Posted: | June 11, 2014 |
Last Verified: | June 2014 |
Additional relevant MeSH terms:
Bile Duct Neoplasms Cholangiocarcinoma Jaundice Jaundice, Obstructive Head and Neck Neoplasms Biliary Tract Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Bile Duct Diseases |
Biliary Tract Diseases Digestive System Diseases Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Hyperbilirubinemia Pathologic Processes Skin Manifestations Signs and Symptoms |