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

Sponsor:

Information provided by (Responsible Party):

Sun-Whe Kim, Seoul National University Hospital

Study Description

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.

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 Design


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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Cholangiocarcinoma

Genetic and Rare Diseases Information Center resources: Bile Duct Cancer

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: PTBD biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer	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	Procedure: biliary drainage biliary drainage via PTBD or ERBD/ENBD

Outcome Measures

Primary Outcome Measures :

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)

Secondary Outcome Measures :

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

Eligibility Criteria

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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

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)

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Korea, Republic of
Department of Surgery, Seoul National University Hospital
Seoul, Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

More Information

Publications:

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.


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

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