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

Study Overview
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Brief Summary
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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
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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

Official Title
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Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?

Conditions
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Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent

Intervention / Treatment
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* Device: Fully covered metal stents
* Device: Plastic stents


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plastic stents<br>Plastic stents are inserted by ERCP | Device: Plastic stents<br>* Plastic stents were inserted by ERCP<br>* Other names: Biliary stents, Cook Endoscopy, Winston-Salem, NC;|
| Experimental: Fully covered metal stents<br>Fully covered metal stents are inserted by ERCP | Device: Fully covered metal stents<br>* Fully covered metal stents were inserted by ERCP<br>* Other names: BONASTENT, Standard Sci Tech, Seoul, Korea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events related to the stent insertion | Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage. | up to 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Re-intervention rate | 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. | up to 4weeks | 
| Hospital stay | Hospital stay is defined as the period between the date of stent insertion and that of discharge. | up to 1months | 
| Surgical outcomes | Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery. | up to 1months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-expandable metal stent; plastic stent