Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer
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|ClinicalTrials.gov Identifier: NCT02787512|
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : February 12, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Jaundice Periampullary Cancer||Device: Stent||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||A Randomized Controlled Trial for Preoperative Biliary Drainage With Metal Versus Plastic Stents in Patients With Periampullary Cancer|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||January 10, 2019|
|Actual Study Completion Date :||January 10, 2019|
Active Comparator: Plastic stent
10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent)
Endoscopic biliary stent insertion
Experimental: Uncovered metal stent
Uncovered metal stent (WallFlex® Biliary RX stent)
Endoscopic biliary stent insertion
- Reintervention rate until operation [ Time Frame: Between preoperative biliary drainage and surgery ]Between preoperative biliary drainage and surgery, reintervention (re-preoperative biliary drainage) would be checked and analyzed.
- Other complication rate associated with endoscopic stent insertion and stent indwell [ Time Frame: Between preoperative biliary drainage and surgery ]Until surgery, preoperative biliary drainage associated with complication would be checked and analyzed.
- Rate of decrease of total bilirubin [ Time Frame: Between preoperative biliary drainage and surgery ]Amount of decrease of total bilirubin between preoperative biliary drainage and surgery would be checked.
- Time to operation [ Time Frame: Between preoperative biliary drainage and surgery ]Interval between preoperative biliary drainage and surgery would be checked.
- Time to hospital discharge after pancreaticoduodenectomy [ Time Frame: 6 month ]Interval between surgery and discharge would be checked.
- Mortality until 3 months after pancreaticoduodenectomy [ Time Frame: 3 month ]The mortality rate would be calculated
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787512
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam, Gyeonggi-do, Korea, Republic of, 463-707|
|Gachon University Gil Medical Center|
|Incheon, Korea, Republic of|
|Principal Investigator:||Jaihwan Kim, MD||Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital|