Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Bile Duct Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134276
• Other study ID #: H-1001-047-307
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: June 7, 2014
• Start date: August 2010
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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)

Study Design

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

Related Conditions & MeSH terms

• Ampulla of Vater Cancer
• Bile Duct Cancer
• Cholangiocarcinoma
• Jaundice
• Jaundice, Obstructive
• Pancreas Head Cancer
• Periampullary Cancers With Obstructive Jaundice

Intervention

Procedure:
• biliary drainage
biliary drainage via PTBD or ERBD/ENBD

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Infectious Complications After Biliary Drainage	at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)	within 120 days after drainage	No
Secondary	Change in Total Serum Bilirubin After Drainage	Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)	within 14 days after drainage	No
Secondary	Total Hospital Cost During Admission After Biliary Drainage	Total hospital cost during admission after Biliary Drainage in US dollars	during hospital stay for biliary drainage procedure	No