Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
NCT ID: NCT01134276
Last Updated: 2014-06-11
Study Results
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View full resultsBasic Information
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COMPLETED
NA
211 participants
INTERVENTIONAL
2010-08-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PTBD
biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
biliary drainage
biliary drainage via PTBD or ERBD/ENBD
ERBD
biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer
biliary drainage
biliary drainage via PTBD or ERBD/ENBD
Interventions
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biliary drainage
biliary drainage via PTBD or ERBD/ENBD
Eligibility Criteria
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Inclusion Criteria
* 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
* duodenal cancer
* biliary drainage before randomization
* previous chemotherapy or radiotherapy
* uncontrollable active infection except cholangitis
* severe comorbid disease (cardiac, pulmonary, cerebrovascular)
20 Years
85 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Sun-Whe Kim
Professor
Locations
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Department of Surgery, Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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van der Gaag NA, de Castro SM, Rauws EA, Bruno MJ, van Eijck CH, Kuipers EJ, Gerritsen JJ, Rutten JP, Greve JW, Hesselink EJ, Klinkenbijl JH, Rinkes IH, Boerma D, Bonsing BA, van Laarhoven CJ, Kubben FJ, van der Harst E, Sosef MN, Bosscha K, de Hingh IH, Th de Wit L, van Delden OM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial). BMC Surg. 2007 Mar 12;7:3. doi: 10.1186/1471-2482-7-3.
Speer AG, Cotton PB, Russell RC, Mason RR, Hatfield AR, Leung JW, MacRae KD, Houghton J, Lennon CA. Randomised trial of endoscopic versus percutaneous stent insertion in malignant obstructive jaundice. Lancet. 1987 Jul 11;2(8550):57-62. doi: 10.1016/s0140-6736(87)92733-4.
Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg. 2002 Jul;236(1):17-27. doi: 10.1097/00000658-200207000-00005.
Saiki S, Chijiiwa K, Komura M, Yamaguchi K, Kuroki S, Tanaka M. Preoperative internal biliary drainage is superior to external biliary drainage in liver regeneration and function after hepatectomy in obstructive jaundiced rats. Ann Surg. 1999 Nov;230(5):655-62. doi: 10.1097/00000658-199911000-00007.
Other Identifiers
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H-1001-047-307
Identifier Type: -
Identifier Source: org_study_id
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