Clinical trial NCT01134276: Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periampullary Cancers With Obstructive Jaundice
Pancreas Head Cancer
Bile Duct Cancer
Ampulla of Vater Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 211
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Preoperative biliary drainage methods include percutaneous transhepatic biliary drainage (PTBD), endoscopic nasobiliary drainage (ENBD), and endoscopic retrograde biliary drainage (ERBD). Endoscopic biliary drainages often induce peritumoral inflammation and it increase difficulties in determining a proper resection margin. The purpose of this study is to compare the clinicopathological outcomes according to the methods of preoperative biliary drainage in periampullary cancers causing obstructive jaundice, and to find out a proper biliary drainage method.


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of Infectious Complications After Biliary Drainage
timeFrame: within 120 days after drainage
Secondary outcomes:
measure: Change in Total Serum Bilirubin After Drainage
timeFrame: within 14 days after drainage
measure: Total Hospital Cost During Admission After Biliary Drainage
timeFrame: during hospital stay for biliary drainage procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Seoul National University Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.