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

This study has been completed.
Information provided by (Responsible Party):
Tea Jun Song, Inje University Identifier:
First received: February 5, 2013
Last updated: August 2, 2015
Last verified: August 2015

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 Intervention
Periampullary 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?

Further study details as provided by Inje University:

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

Secondary Outcome Measures:
  • Re-intervention rate [ Time Frame: up to 4weeks ] [ Designated as safety issue: No ]
    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.

  • Hospital stay [ Time Frame: up to 1months ] [ 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 1months ] [ Designated as safety issue: Yes ]
    Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.

Enrollment: 86
Study Start Date: January 2012
Study Completion Date: February 2015
Primary Completion Date: December 2014 (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 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


Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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%)
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

No publications provided

Responsible Party: Tea Jun Song, Assistant Professor, Inje University Identifier: NCT01789502     History of Changes
Other Study ID Numbers: IB-1210-034
Study First Received: February 5, 2013
Last Updated: August 2, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by Inje University:
self-expandable metal stent; plastic stent

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases processed this record on October 13, 2015