Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Controlled Trial for Preoperative Biliary Drainage With Metal Versus Plastic Stents in Patients With Periampullary Cancer

Conditions
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Jaundice, Periampullary Cancer

Intervention / Treatment
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* Device: Stent


Participation Criteria
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Eligibility Criteria
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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 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

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plastic stent<br>10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent) | Device: Stent<br>* Endoscopic biliary stent insertion<br>|
| Experimental: Uncovered metal stent<br>Uncovered metal stent (WallFlex® Biliary RX stent) | Device: Stent<br>* Endoscopic biliary stent insertion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERCP, stent, preoperative biliary drainage