Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Inje University
- Enrollment
- 86
- Locations
- 3
- Primary Endpoint
- Adverse events related to the stent insertion
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- 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%)
Arms & Interventions
Plastic stents
Plastic stents are inserted by ERCP
Intervention: Plastic stents (Device)
Fully covered metal stents
Fully covered metal stents are inserted by ERCP
Intervention: Fully covered metal stents (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Re-intervention rate(up to 4weeks)
- Hospital stay(up to 1months)
- Surgical outcomes(up to 1months)
Investigators
Tea Jun Song
Assistant Professor
Inje University