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Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
self-expandable metal stent insertion(covered stent)
self-expandable metal stent insertion(uncovered stent)
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 20~85-year-old patients with malignant colorectal obstruction either by primary CRC or extracolonic malignancy
  • Patients with clinical obstructive symptoms confirmed by CT or colonoscopy

Exclusion Criteria:

  • Patients with evidence of bowel perforation or peritonitis
  • Cause of obstruction other than malignancy (bowel adhesion or benign stricture)
  • Multiple stricture
  • Lower rectal cancer obstruction (AV <5cm)

Sites / Locations

  • Department of Internal Medicine, Yonsei University College of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

covered stent

uncovered stent

Arm Description

newly designed covered stent group

currently used uncovered stent group

Outcomes

Primary Outcome Measures

Duration of stent patency between stent insertion and recurrence of obstructive symptoms
Time between stent insertion and recurrence of obstructive symptoms caused by tumor ingrowth, tumor overgrowth, or stent migration after stent placement

Secondary Outcome Measures

Number of patients with technical success
Technical success: Adequate deployment across the entire length of the malignant strictures and proper stent expansion
Number of patients with clinical success
Clinical success: Relief from obstructive symptoms as a result of sufficient improvement in stool passage without additional need for endoscopic or surgical re-intervention within 48 hours
Number of patients with complications
Complications: stent obstruction, migration, perforation, bleeding, tenesmus, anal pain

Full Information

First Posted
December 10, 2015
Last Updated
March 25, 2019
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02640781
Brief Title
Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction
Official Title
Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction: a Prospective, Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
August 2019 (Anticipated)
Study Completion Date
August 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Acute colorectal obstruction has been reported to occur in 7 - 29% of all colorectal malignancies, but emergent surgical decompression is associated with high morbidity and mortality rates. Recently, self-expandable metal stents(SEMS) have been suggested as an alternative to surgery and effectively decompress the colonic obstruction and allow for bowel preparation and elective surgery. Theoretically, SEMSs are classified into uncovered stents and covered stents. Covered stents have the advantage of less frequent stent occlusion by tumor in-growth and the disadvantage of a high risk of stent migration, whereas uncovered stents are associated with less stent migration, although they appear to be more prone to tumor ingrowth. To overcome the drawbacks of conventional stents, a double-layered combination covered stent was developed. In the present study, the investigators evaluated the efficacy and safety of the newly designed covered stent by comparing it with the uncovered stent in patients with malignant colorectal obstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
covered stent
Arm Type
Experimental
Arm Description
newly designed covered stent group
Arm Title
uncovered stent
Arm Type
Active Comparator
Arm Description
currently used uncovered stent group
Intervention Type
Procedure
Intervention Name(s)
self-expandable metal stent insertion(covered stent)
Intervention Description
Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal covered stent delivery catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.
Intervention Type
Procedure
Intervention Name(s)
self-expandable metal stent insertion(uncovered stent)
Intervention Description
Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal stent delivery uncovered catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.
Primary Outcome Measure Information:
Title
Duration of stent patency between stent insertion and recurrence of obstructive symptoms
Description
Time between stent insertion and recurrence of obstructive symptoms caused by tumor ingrowth, tumor overgrowth, or stent migration after stent placement
Time Frame
2 years after the procedure
Secondary Outcome Measure Information:
Title
Number of patients with technical success
Description
Technical success: Adequate deployment across the entire length of the malignant strictures and proper stent expansion
Time Frame
2 years after the procedure
Title
Number of patients with clinical success
Description
Clinical success: Relief from obstructive symptoms as a result of sufficient improvement in stool passage without additional need for endoscopic or surgical re-intervention within 48 hours
Time Frame
2 years after the procedure
Title
Number of patients with complications
Description
Complications: stent obstruction, migration, perforation, bleeding, tenesmus, anal pain
Time Frame
2 years after the procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 20~85-year-old patients with malignant colorectal obstruction either by primary CRC or extracolonic malignancy Patients with clinical obstructive symptoms confirmed by CT or colonoscopy Exclusion Criteria: Patients with evidence of bowel perforation or peritonitis Cause of obstruction other than malignancy (bowel adhesion or benign stricture) Multiple stricture Lower rectal cancer obstruction (AV <5cm)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tae-Il Kim, MD, Ph.D
Phone
82-2-2228-1965
Email
taeilkim@yuhs.ac
Facility Information:
Facility Name
Department of Internal Medicine, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAE IL KIM, MD
Phone
82-2-2228-1965
Email
taeilkim@yuhs.ac

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Efficacy Between a Newly Designed Covered Stent and Uncovered Stent for Malignant Colorectal Obstruction

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