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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01789502
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : August 4, 2015
Information provided by (Responsible Party):
Tea Jun Song, Inje University

Brief Summary:
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, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.

Condition or disease Intervention/treatment Phase
Periampullary Cancer Complications of Surgical Procedures or Medical Care Disorder of Bile Duct Stent Device: Fully covered metal stents Device: Plastic stents Not Applicable

Detailed Description:

Pancreaticoduodenectomy 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 incidence of stent-related adverse events, the re-intervention rate, 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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?
Study Start Date : January 2012
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Adverse events related to the stent insertion [ Time Frame: up to 4weeks ]
    Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.

Secondary Outcome Measures :
  1. Re-intervention rate [ Time Frame: up to 4weeks ]
    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.

  2. Hospital stay [ Time Frame: up to 1months ]
    Hospital stay is defined as the period between the date of stent insertion and that of discharge.

  3. Surgical outcomes [ Time Frame: up to 1months ]
    Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Older than 20 years old of age
  • Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary 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%)

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 identifier (NCT number): NCT01789502

Korea, Republic of
Inje University Ilsan Paik Hospital
Koyang, Gyeonggi-do, Korea, Republic of, 411-706
Daejun Eulji University Hospital
Daejun, Korea, Republic of, 302-799
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Inje University
Principal Investigator: Tae Jun Song, MD, PhD Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Tea Jun Song, Assistant Professor, Inje University Identifier: NCT01789502     History of Changes
Other Study ID Numbers: IB-1210-034
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: August 4, 2015
Last Verified: August 2015

Keywords provided by Tea Jun Song, Inje University:
self-expandable metal stent; plastic stent

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases