Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 26, 2016
First Posted Date  ICMJE June 1, 2016
Last Update Posted Date February 12, 2019
Actual Study Start Date  ICMJE June 2016
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
Reintervention rate until operation [ Time Frame: 3 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2016)
  • Other complication rate associated with endoscopic stent insertion and stent indwell [ Time Frame: 3 month ]
  • Rate of decrease of total bilirubin [ Time Frame: 3 month ]
  • Time to operation [ Time Frame: 3 month ]
  • Time to hospital discharge after pancreaticoduodenectomy [ Time Frame: 6 month ]
  • Mortality until 3 months after pancreaticoduodenectomy [ Time Frame: 6 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preoperative Biliary Drainage With Metal Versus Plastic Stents in Periampullary Cancer
Official Title  ICMJE A Randomized Controlled Trial for Preoperative Biliary Drainage With Metal Versus Plastic Stents in Patients With Periampullary Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Jaundice
  • Periampullary Cancer
Intervention  ICMJE Device: Stent
Endoscopic biliary stent insertion
Study Arms  ICMJE
  • Active Comparator: Plastic stent
    10 Fr plastic stent (Percuflex Amsterdam® or C-flex pigtail® or Advanix® Biliary stent)
    Intervention: Device: Stent
  • Experimental: Uncovered metal stent
    Uncovered metal stent (WallFlex® Biliary RX stent)
    Intervention: Device: Stent
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 26, 2016)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 10, 2019
Actual Primary Completion Date January 10, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02787512
Other Study ID Numbers  ICMJE SNUBH-IMGPB-2016-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Boston Scientific Corporation
Investigators  ICMJE
Principal Investigator: Jaihwan Kim, MD Division of Gastroenterology, Department of Internal Medicine, Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP