Jaundice, Periampullary Cancer
Conditions
Keywords
ERCP, stent, preoperative biliary drainage
Brief summary
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.
Detailed description
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.
Interventions
DEVICEStent
Endoscopic biliary stent insertion
Sponsors
Boston Scientific Corporation
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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 * Cholangitis defined as revised Tokyo guidelines * Level of total bilirubin \>= 10mg/dL * Expected time to operation \>= 7 days
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: * Patients who take clopidogrel within 5 days before PBD * Patients who take warfarin within 2 days before PBD * Patients who receive heparin within 1 days before PBD D. Patients with pregnancy or suspected pregnancy E. Patients who are currently enrolled in another investigational trials that would directly interfere with current study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention rate until operation | Between preoperative biliary drainage and surgery | Between preoperative biliary drainage and surgery, reintervention (re-preoperative biliary drainage) would be checked and analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other complication rate associated with endoscopic stent insertion and stent indwell | 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 | Between preoperative biliary drainage and surgery | Amount of decrease of total bilirubin between preoperative biliary drainage and surgery would be checked. |
| Time to operation | Between preoperative biliary drainage and surgery | Interval between preoperative biliary drainage and surgery would be checked. |
| Time to hospital discharge after pancreaticoduodenectomy | 6 month | Interval between surgery and discharge would be checked. |
| Mortality until 3 months after pancreaticoduodenectomy | 3 month | The mortality rate would be calculated |
Countries
South Korea
Outcome results
None listed