Comparison Between Internal And External Preoperative Biliary Drainage In Periampullary Cancers

Study Overview

Comparison Between Internal and External Preoperative Biliary Drainage in Periampullary Cancers

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.

N/A

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

PROCEDURE: biliary drainage

H-1001-047-307

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-05-04	Results First Submitted 2014-04-07	Last Update Submitted that met QC Criteria 2014-06-07
First Submitted that Met QC Criteria 2010-05-27	Results First Submitted that Met QC Criteria 2014-06-07	Last Update Posted (ESTIMATED) 2014-06-11
First Posted (ESTIMATED) 2010-05-31	Results First Posted 2014-06-11	Last Verified 2014-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/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

Participant Group/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

Primary Outcome Measures	Measure Description	Time Frame
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 Outcome Measures	Measure Description	Time Frame
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
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

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

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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. doi: 10.1186/1471-2482-7-3.
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. doi: 10.1016/s0140-6736(87)92733-4.
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.
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.

Learn

Resources

Patients

Caregivers

Clinical Trial Record