Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage
|Periampullary Cancer Complications of Surgical Procedures or Medical Care Disorder of Bile Duct Stent||Device: Fully covered metal stents Device: Plastic stents|
|Study Design:||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?|
- 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.
- 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.
- Hospital stay [ Time Frame: up to 1months ]Hospital stay is defined as the period between the date of stent insertion and that of discharge.
- 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.
|Study Start Date:||January 2012|
|Study Completion Date:||February 2015|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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
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
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Tae Jun Song, MD, PhD||Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea|