Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Inje University
Sponsor:
Information provided by (Responsible Party):
Tea Jun Song, Inje University
ClinicalTrials.gov Identifier:
NCT01789502
First received: February 5, 2013
Last updated: February 8, 2013
Last verified: February 2013
  Purpose

This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer and pancreas head cancer with respect to the re-intervention rate, the incidence of stent-related adverse events, the effectiveness of biliary drainage, surgical outcomes and hospital stays.


Condition Intervention
Biliary Tract Cancer
Complications of Surgical Procedures or Medical Care
Disorder of Bile Duct Stent
Device: Fully covered metal stents
Device: Plastic stents

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?

Resource links provided by NLM:


Further study details as provided by Inje University:

Primary Outcome Measures:
  • Re-intervention rate [ Time Frame: up to 4weeks ] [ Designated as safety issue: No ]
    Primary outcome parameter is re-intervention rate from stent insertion to surgery. Re-intervention is defined as endoscopic retrograde cholangiopancreatography or percutaneous transhepatic biliary drainage procedures which are required to achieve adequate preoperative biliary drainage after stent insertion.


Secondary Outcome Measures:
  • Adverse events related to the stent insertion [ Time Frame: up to 4weeks ] [ Designated as safety issue: Yes ]
    Adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis or hemorrhage.

  • Hospital stay [ Time Frame: up to 2months ] [ Designated as safety issue: No ]
    Hospital stay is defined as the period between the date of stent insertion and that of discharge.

  • Surgical outcomes [ Time Frame: up to 2months ] [ Designated as safety issue: Yes ]
    Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.


Estimated Enrollment: 100
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Plastic stents
Plastic stents are inserted by ERCP
Device: Plastic stents
Plastic stents were inserted by ERCP
Other Name: Biliary stents, Cook Endoscopy, Winston-Salem, NC
Experimental: Fully covered metal stents
Fully covered metal stents are inserted by ERCP
Device: Fully covered metal stents
Fully covered metal stents were inserted by ERCP
Other Name: BONASTENT, Standard Sci Tech, Seoul, Korea

Detailed Description:

Pancreaticoduodenectomy (Whipple's procedure) is curative option in periampullary tumor. Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in patients with resectable disease to relieve biliary obstruction, which is thought to impair immune response, clotting, and other functions that impact intraoperative and postoperative outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with biliary stenting has become standard practice in patients with periampullary malignancies. In a recent multicenter randomized trial, patients who underwent preoperative biliary drainage had a 74% rate of complications compared with 39% for those who directly underwent surgery without preoperative biliary drainage. In this trial, however, all patients underwent placement of plastic stents. In ERCP, self-expandable metal stent are being increasingly placed for palliation of malignant biliary obstruction. Compared with plastic stents, self-expandable metal stents have large caliber and have demonstrated longer patency duration. Even in patients with resectable malignant disease, self-expandable metal stents which are placed below the level of transection may not impair technical outcomes at surgery and can be safely removed along with the surgical specimen.

This prospective study is designed to compare the re-intervention rate, the incidence of stent-related adverse events, the effectiveness of biliary drainage, surgical outcomes and hospital stays in patients with periamupllary tumors who are undergone with self-expandable metal stents or plastic stents placement for preoperative biliary drainage

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 20 years old of age
  • Obstructive jaundice due to distal common bile duct cancer and pancreas head cancer
  • No evidence of distant metastases or locally advanced tumor

Exclusion Criteria:

  • Unresectable stage of cancer
  • Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
  • Severe gastric outlet obstruction or duodenal obstruction
  • Severe comorbidity (Karnofsky<50%)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789502

Contacts
Contact: Tae Jun Song, MD, PhD +82-31-910-7114 tjsong@paik.ac.kr

Locations
Korea, Republic of
Inje University Ilsan Paik Hospital Recruiting
Koyang, Gyeonggi-do, Korea, Republic of, 411-706
Contact: Tae Jun Song, MD, PhD    +82-31-910-7114    tjsong@paik.ac.kr   
Daejun Eulji University Hospital Recruiting
Daejun, Korea, Republic of, 302-799
Contact: Ji Woong Jang, MD    +82-1899-0001    jj98w@naver.com   
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sang Soo Lee, MD, PhD    +82-2-3010-3180    ssleedr@amc.seoul.kr   
Sponsors and Collaborators
Inje University
Investigators
Principal Investigator: Tae Jun Song, MD, PhD Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea
  More Information

No publications provided

Responsible Party: Tea Jun Song, Assistant Professor, Inje University
ClinicalTrials.gov Identifier: NCT01789502     History of Changes
Other Study ID Numbers: IB-1210-034
Study First Received: February 5, 2013
Last Updated: February 8, 2013
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Bile Duct Diseases
Cholestasis
Biliary Tract Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014