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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Currently, routine preoperative biliary drainage (PBD) was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.
The aim of this clinical trial is to demonstrate non-inferiority of uncovered self-expandable metal stent to plastic stent for PBD by endoscopic retrograde cholangiopancreatography in patients with periampullary cancer undergoing curative intent pancreaticoduodenectomy.
Jaundice is one of the most common symptoms in patients with periampullary cancers including pancreatic cancer, common bile duct (CBD) cancer, ampulla of Vater (AoV) cancer, and duodenal cancer. Traditionally, preoperative biliary drainage (PBD) was routinely performed in these cancers because it might favorably influence sepsis, endotoxemia, and intravascular coagulation. However, a recent randomized control study reported that routine PBD in patients undergoing surgery for cancer of the pancreatic head increases the rate of complications. Therefore, routine PBD was not recommended. However, PBD is still necessary in case of patients with cholangitis or very high level of bilirubin or patients who are expected to receive delayed surgery.
In these patients with necessity of PBD, a plastic stent (PS) has been used because it is good for temporary use with cheap prices. However, it is sometimes occluded before surgery or not enough for rapid decompressing jaundice mainly because of its short diameter. In this aspect, a self-expandable metal stent (SEMS) has strength compared to PS because it has a longer diameter which enables rapid decompression with a fewer events of occlusion. However, SEMS is much more expensive than PS and the exact length of stent is more critical.
Although there are still lack of evidence which compares the results between PS and SEMS, National Comprehensive Cancer Network (NCCN) guidelines recently recommended the use of a short SEMS for pancreatic adenocarcinoma patients with cholangitis or fever. However, we needed more concrete evidence about this principle.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plastic stent | Active Comparator | 10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent) |
|
| Uncovered metal stent | Experimental | Uncovered metal stent (WallFlex® Biliary RX stent) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stent | Device | Endoscopic biliary stent insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reintervention rate until operation | Between preoperative biliary drainage and surgery, reintervention (re-preoperative biliary drainage) would be checked and analyzed. | Between preoperative biliary drainage and surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Other complication rate associated with endoscopic stent insertion and stent indwell | Until surgery, preoperative biliary drainage associated with complication would be checked and analyzed. | Between preoperative biliary drainage and surgery |
| Rate of decrease of total bilirubin |
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Inclusion Criteria:
A. Patients 20-80 years old B. Patients with surgically resectable periampullary cancer on CT scans with or without MRI or PET-CT scans C. ECOG Performance score 0 or 1 D. Patients who need preoperative biliary drainage (PBD) because of one or more of following causes
Exclusion Criteria:
A. Patients who received previous endoscopic biliary drainage or percutaneous biliary drainage B. Patients with acute pancreatitis before PBD
C. Patients with bleeding tendency or coagulopathy or anticoagulation therapy as follows:
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| Name | Affiliation | Role |
|---|---|---|
| Jaihwan Kim, MD | Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea | ||
| Gachon University Gil Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20071702 | Background | van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230. | |
| 23205306 |
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| ID | Term |
|---|---|
| D007565 | Jaundice |
| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
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| ID | Term |
|---|---|
| D015607 | Stents |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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Amount of decrease of total bilirubin between preoperative biliary drainage and surgery would be checked. |
| Between preoperative biliary drainage and surgery |
| Time to operation | Interval between preoperative biliary drainage and surgery would be checked. | Between preoperative biliary drainage and surgery |
| Time to hospital discharge after pancreaticoduodenectomy | Interval between surgery and discharge would be checked. | 6 month |
| Mortality until 3 months after pancreaticoduodenectomy | The mortality rate would be calculated | 3 month |
| Incheon |
| South Korea |
| Adams MA, Anderson MA, Myles JD, Khalatbari S, Scheiman JM. Self-expanding metal stents (SEMS) provide superior outcomes compared to plastic stents for pancreatic cancer patients undergoing neoadjuvant therapy. J Gastrointest Oncol. 2012 Dec;3(4):309-13. doi: 10.3978/j.issn.2078-6891.2011.050. |
| 21373939 | Background | Decker C, Christein JD, Phadnis MA, Wilcox CM, Varadarajulu S. Biliary metal stents are superior to plastic stents for preoperative biliary decompression in pancreatic cancer. Surg Endosc. 2011 Jul;25(7):2364-7. doi: 10.1007/s00464-010-1552-6. Epub 2011 Mar 4. |
| D012816 | Signs and Symptoms |