Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

NCT01134276 | Completed Results DMC

• 1 other identifier: H-1001-047-307
• Study Type: interventional
• Target: 211
• Locations: 1 country
• Sites: 1

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.

Conditions

Periampullary Cancers With Obstructive Jaundice; Pancreas Head Cancer; Bile Duct Cancer; Ampulla of Vater Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change in Total Serum Bilirubin After Drainage

  within 14 days after drainage

• Total Hospital Cost During Admission After Biliary Drainage

  during hospital stay for biliary drainage procedure

Study Arms (2)

PTBD

ACTIVE COMPARATOR

biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer

Procedure: biliary drainage

ERBD

ACTIVE COMPARATOR

biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer

Procedure: biliary drainage

Interventions

biliary drainage PROCEDURE

biliary drainage via PTBD or ERBD/ENBD

ERBD; PTBD

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Department of Surgery, Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (4)

• 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.

  PMID: 17352805 BACKGROUND

• 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.

  PMID: 2439854 BACKGROUND

• 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.

  PMID: 12131081 BACKGROUND

• 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.

  PMID: 10561089 BACKGROUND

MeSH Terms

Conditions

Bile Duct Neoplasms

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Results Point of Contact

• Title: Sun-Whe Kim
• Organization: Seoul National University College of Medicine

sunkim@plaza.snu.ac.kr

+82-2-2072-2315

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: May 31, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 11, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-06

Locations

KR (1)