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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
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Seoul National University Hospital

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.


Condition or disease Intervention/treatment Phase
Jaundice Periampullary Cancer Device: Stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Active Comparator: Plastic stent
10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent)
Device: Stent
Endoscopic biliary stent insertion

Experimental: Uncovered metal stent
Uncovered metal stent (WallFlex® Biliary RX stent)
Device: Stent
Endoscopic biliary stent insertion




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Time to operation [ Time Frame: Between preoperative biliary drainage and surgery ]
    Interval between preoperative biliary drainage and surgery would be checked.

  4. Time to hospital discharge after pancreaticoduodenectomy [ Time Frame: 6 month ]
    Interval between surgery and discharge would be checked.

  5. Mortality until 3 months after pancreaticoduodenectomy [ Time Frame: 3 month ]
    The mortality rate would be calculated



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Seoul National University Hospital
Boston Scientific Corporation
Investigators
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Principal Investigator: Jaihwan Kim, MD Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital
Publications:
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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02787512    
Other Study ID Numbers: SNUBH-IMGPB-2016-01
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Seoul National University Hospital:
ERCP
stent
preoperative biliary drainage
Additional relevant MeSH terms:
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Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations