본문바로가기



  • Status : Approved
    • First Submitted Date : 2018/11/06
    • Registered Date : 2019/01/11
    • Last Updated Date : 2018/12/05
  • 페이스북공유하기
  • 트위터공유하기
  • 구글플러스공유하기
  • 카카오스토리공유하기
  • 네이버밴드공유하기
  • 출력

1. Background

Background Information
CRIS
Registration Number
KCT0003421 
Unique Protocol ID KNUCH 2018-03-042-002 
Public/Brief Title Carbon dioxide insufflation during endoscopic colorectal stenting for malignant colorectal obstruction: a randomized controlled trial 
Scientific Title Carbon dioxide insufflation during endoscopic colorectal stenting for malignant colorectal obstruction: a randomized controlled trial  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol  
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
Not applicable

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number KNUCH 2018-03-042-002 
Approval Date 2018-04-27 
Institutional Review Board  
Name Kyungpook National University Medical Center Institutional Review Board 
Address 807, Hoguk-ro, Buk-gu, Daegu 
Telephone 053-200-2162 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Hyun Seok Lee 
Title Professor 
Telephone +82-53-200-2603 
Affiliation Kyungpook National University Medical Center 
Address 807, Hoguk-ro, Buk-gu, Daegu 
Contact Person for Public Queries
Name Hyun Seok Lee 
Title Professor 
Telephone +82-53-200-2603 
Affiliation Kyungpook National University Medical Center 
Address 807, Hoguk-ro, Buk-gu, Daegu 
Contact Person for Updating Information
Name Hyun Seok Lee 
Title Professor 
Telephone +82-53-200-2603 
Affiliation Kyungpook National University Medical Center 
Address 807, Hoguk-ro, Buk-gu, Daegu 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-05-08 , Actual
Target Number of Participant 50
Primary Completion Date
Study Completion Date
Recruitment Status by Participating Study Site 1
Name of Study Site Kyungpook National University Medical Center 
Recruitment Status Recruiting  
Date of First Enrollment 2018-05-08 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Kyungpook National University Medical Center 
Organization Type Medical Institute  
Project ID  

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Kyungpook National University Medical Center 
Organization Type Medical Institute  

7. Study Summary

Study Summary Information
Lay Summary Air insufflation may cause abdominal distension during colorectal stenting procedure. Recent study showed that carbon dioxide (CO2) insufflation decreased abdominal distension during usual colonoscopy. There is no study about CO2 insufflation during colorectal stenting. The aim of this study is to evaluate the effectiveness of CO2 insufflation for decreasing abdominal distention during colorectal stenting.  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Prospective    
Target Number of Participant 50
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
patient with malignant colorectal obstruction, carbon dioxide group 
Cohort/Group
Description
patient with malignant colorectal obstruction being identified on imaging study. carbon dioxide insufflation through endoscope during stenting procedure. evaluation of abdominal pain, evaluation of abdominal distension, evaluation of abdominal discomfort, measurement of abdominal circumference, before and after procedure. comparison of stent success rate 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
patient with malignant colorectal obstruction, air group 
Cohort/Group
Description
patient with malignant colorectal obstruction being identified on imaging study. air insufflation through endoscope during stenting procedure. evaluation of abdominal pain, evaluation of abdominal distension, evaluation of abdominal discomfort, measurement of abdominal circumference, before and after procedure. comparison of stent success rate. 
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description adult visiting Kyungpook National University Medical Center  
Sampling Method simple random sampling  
Condition(s)/Problem(s) * Neoplasms
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 18 Year ~ No Limit
Description patient with malignant colorectal obstruction being identified on imaging study
patient who need colorectal stenting procedure  
Exclusion Criteria patient with benign colorectal obstruction  
Healthy Volunteers No

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Efficacy 
Primary Outcome(s) 1 
Outcome change of abdominal symptoms and abdominal circumference, before and after stenting procedure 
Timepoint before and after stenting procedure 
Secondary Outcome(s) 1 
Outcome success rate of stent 
Timepoint 3 days after stenting procedure 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information
Sharing Statement No 
  • 출력
Quick Link
자주하시는 질문
Q&A
등록절차
입력항목설명집