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Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

Primary Purpose

Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
biliary drainage
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periampullary Cancers With Obstructive Jaundice

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Department of Surgery, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PTBD

ERBD

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
Total Hospital Cost During Admission After Biliary Drainage
Total hospital cost during admission after Biliary Drainage in US dollars

Full Information

First Posted
May 4, 2010
Last Updated
June 7, 2014
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01134276
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Cancers With Obstructive Jaundice, Pancreas Head Cancer, Bile Duct Cancer, Ampulla of Vater Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
211 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PTBD
Arm Type
Active Comparator
Arm Description
biliary drainage : PTBD procedure for obstructive jaundice in patients with periampullary cancer
Arm Title
ERBD
Arm Type
Active Comparator
Arm Description
biliary drainage : ERBD/ENBD procedure for obstructive jaundice in patients with periampullary cancer
Intervention Type
Procedure
Intervention Name(s)
biliary drainage
Intervention Description
biliary drainage via PTBD or ERBD/ENBD
Primary Outcome Measure Information:
Title
Incidence of Infectious Complications After Biliary Drainage
Description
at least 90 days after operation change in serum bilirubin cholangitis blood test (complete blood cell count, liver function test, CRP)
Time Frame
within 120 days after drainage
Secondary Outcome Measure Information:
Title
Change in Total Serum Bilirubin After Drainage
Description
Effect of reducing serum total bilirubin after drainage in terms of Daily diminution of bilirubin(mg/dL/day)
Time Frame
within 14 days after drainage
Title
Total Hospital Cost During Admission After Biliary Drainage
Description
Total hospital cost during admission after Biliary Drainage in US dollars
Time Frame
during hospital stay for biliary drainage procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Department of Surgery, Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
17352805
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.
Results Reference
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PubMed Identifier
2439854
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.
Results Reference
background
PubMed Identifier
12131081
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.
Results Reference
background
PubMed Identifier
10561089
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.
Results Reference
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Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

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