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Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

Primary Purpose

Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fully covered metal stents
Plastic stents
Sponsored by
Inje University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periampullary Cancer focused on measuring self-expandable metal stent; plastic stent

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Older than 20 years old of age
  • Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer
  • No evidence of distant metastases or locally advanced tumor

Exclusion Criteria:

  • Unresectable stage of cancer
  • Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis)
  • Severe gastric outlet obstruction or duodenal obstruction
  • Severe comorbidity (Karnofsky<50%)

Sites / Locations

  • Inje University Ilsan Paik Hospital
  • Daejun Eulji University Hospital
  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Plastic stents

Fully covered metal stents

Arm Description

Plastic stents are inserted by ERCP

Fully covered metal stents are inserted by ERCP

Outcomes

Primary Outcome Measures

Adverse events related to the stent insertion
Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.

Secondary Outcome Measures

Re-intervention rate
Re-intervention is defined as endoscopic retrograde cholangiopancreatography or percutaneous transhepatic biliary drainage procedures which are required to achieve adequate preoperative biliary drainage after stent insertion.
Hospital stay
Hospital stay is defined as the period between the date of stent insertion and that of discharge.
Surgical outcomes
Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.

Full Information

First Posted
February 5, 2013
Last Updated
August 2, 2015
Sponsor
Inje University
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1. Study Identification

Unique Protocol Identification Number
NCT01789502
Brief Title
Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage
Official Title
Are Fully Covered Metal Stents Superior to Plastic Stents for Preoperative Biliary Decompression in Malignant Distal Bile Duct Obstruction?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inje University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is a prospective, randomized study to compare of outcome of fully covered metal stents with that of plastic stents for preoperative biliary drainage in distal common bile duct cancer, pancreas head cancer or ampullary cancer with respect to the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays.
Detailed Description
Pancreaticoduodenectomy is curative option in periampullary tumor. Preoperative endoscopic retrograde cholangiopancreatog-raphy (ERCP) is usually undertaken in patients with resectable disease to relieve biliary obstruction, which is thought to impair immune response, clotting, and other functions that impact intraoperative and postoperative outcomes. Despite conflicting data pertaining to preoperative biliary drainage, ERCP with biliary stenting has become standard practice in patients with periampullary malignancies. In a recent multicenter randomized trial, patients who underwent preoperative biliary drainage had a 74% rate of complications compared with 39% for those who directly underwent surgery without preoperative biliary drainage. In this trial, however, all patients underwent placement of plastic stents. In ERCP, self-expandable metal stent are being increasingly placed for palliation of malignant biliary obstruction. Compared with plastic stents, self-expandable metal stents have large caliber and have demonstrated longer patency duration. Even in patients with resectable malignant disease, self-expandable metal stents which are placed below the level of transection may not impair technical outcomes at surgery and can be safely removed along with the surgical specimen. This prospective study is designed to compare the incidence of stent-related adverse events, the re-intervention rate, the effectiveness of biliary drainage, surgical outcomes and hospital stays in patients with periamupllary tumors who are undergone with self-expandable metal stents or plastic stents placement for preoperative biliary drainage

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periampullary Cancer, Complications of Surgical Procedures or Medical Care, Disorder of Bile Duct Stent
Keywords
self-expandable metal stent; plastic stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Plastic stents
Arm Type
Active Comparator
Arm Description
Plastic stents are inserted by ERCP
Arm Title
Fully covered metal stents
Arm Type
Experimental
Arm Description
Fully covered metal stents are inserted by ERCP
Intervention Type
Device
Intervention Name(s)
Fully covered metal stents
Other Intervention Name(s)
BONASTENT, Standard Sci Tech, Seoul, Korea
Intervention Description
Fully covered metal stents were inserted by ERCP
Intervention Type
Device
Intervention Name(s)
Plastic stents
Other Intervention Name(s)
Biliary stents, Cook Endoscopy, Winston-Salem, NC
Intervention Description
Plastic stents were inserted by ERCP
Primary Outcome Measure Information:
Title
Adverse events related to the stent insertion
Description
Primary outcome parameter is adverse events related to the stent insertion includes post-ERCP pancreatitis, cholecystitis, cholangitis, bowel perforation or hemorrhage.
Time Frame
up to 4weeks
Secondary Outcome Measure Information:
Title
Re-intervention rate
Description
Re-intervention is defined as endoscopic retrograde cholangiopancreatography or percutaneous transhepatic biliary drainage procedures which are required to achieve adequate preoperative biliary drainage after stent insertion.
Time Frame
up to 4weeks
Title
Hospital stay
Description
Hospital stay is defined as the period between the date of stent insertion and that of discharge.
Time Frame
up to 1months
Title
Surgical outcomes
Description
Surgical outcomes include the complete resection rate, complication rates related to surgery or the amount of transfusion during surgery.
Time Frame
up to 1months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Older than 20 years old of age Obstructive jaundice due to common bile duct cancer and pancreas head cancer, or ampullary cancer No evidence of distant metastases or locally advanced tumor Exclusion Criteria: Unresectable stage of cancer Preoperative gastric operation that preclude ERCP (total gastrectomy and subtotal gastrectomy with B-II anastomosis) Severe gastric outlet obstruction or duodenal obstruction Severe comorbidity (Karnofsky<50%)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae Jun Song, MD, PhD
Organizational Affiliation
Department of Internal Medicine, Inje University Ilsan Paik Hospital, Koyang, Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inje University Ilsan Paik Hospital
City
Koyang
State/Province
Gyeonggi-do
ZIP/Postal Code
411-706
Country
Korea, Republic of
Facility Name
Daejun Eulji University Hospital
City
Daejun
ZIP/Postal Code
302-799
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
27109456
Citation
Song TJ, Lee JH, Lee SS, Jang JW, Kim JW, Ok TJ, Oh DW, Park DH, Seo DW, Lee SK, Kim MH, Kim SC, Kim CN, Yun SC. Metal versus plastic stents for drainage of malignant biliary obstruction before primary surgical resection. Gastrointest Endosc. 2016 Nov;84(5):814-821. doi: 10.1016/j.gie.2016.04.018. Epub 2016 Apr 22.
Results Reference
derived

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Comparison Between Fully Covered Metal Stents and Plastic Stents in Preoperative Biliary Drainage

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