Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

• Effect of reducing serum total bilirubin after drainage [ Time Frame: within 14 days after drainage ] [ Designated as safety issue: Yes ]
• Peritumoral inflammatory reaction after drainage [ Time Frame: within 7 days after operation ] [ Designated as safety issue: Yes ]
  Bile duct inflammation score measured with H&E staining
• Fibrosis of the bile duct [ Time Frame: within 7 days after operation ] [ Designated as safety issue: Yes ]
  Fibrosis score measured with H&E staining
• Difficulties in dissection around the tumor [ Time Frame: within 1 day after operation ] [ Designated as safety issue: No ]
  Degree of difficulties in dissection around the tumor tissue, which is assessed intraoperatively

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.

• Periampullary Cancers Causing Obstructive Jaundice
• Pancreas Head Cancer
• Bile Duct Cancer
• Ampulla of Vater Cancer

• Active Comparator: PTBD
  Intervention: Procedure: biliary drainage
• Active Comparator: ERBD
  Intervention: Procedure: biliary drainage

• 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.
• 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.
• 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. Review.
• 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.

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)