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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plastic stents | Active Comparator | Plastic stents are inserted by ERCP |
|
| Fully covered metal stents | Experimental | Fully covered metal stents are inserted by ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fully covered metal stents | Device | Fully covered metal stents were inserted by ERCP |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae Jun Song, MD, PhD | Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daejun Eulji University Hospital | Daejun | Daejun | 302-799 | South Korea | ||
| Inje University Ilsan Paik Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27109456 | Derived | Song TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22. |
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| Plastic stents | Device | Plastic stents were inserted by ERCP |
|
|
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 |
| Koyang |
| Gyeonggi-do |
| 411-706 |
| South Korea |
| Asan Medical Center | Seoul | Seoul | 138-736 | South Korea |