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Background Information
1.Background  
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
Institutional Review Board Information
2. Institutional Review Board/Ethics Committee  
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  
Contact Details
3.Contact Details  
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 
Status
4. Status Status  
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
Source of Monetary / Material Support 정보
5. Source of Monetary/Material Support  
Source of Monetary/Material Support1 
- Organization Name Kyungpook National University Medical Center 
- Organization Type Medical Institute  
- Project ID  
Sponsor Organization
6. Sponsor Organization  
Sponsor Organization 1 
- Organization Name Kyungpook National University Medical Center 
- Organization Type Medical Institute  
Study Summary
7. Study Summary  
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.  
Study Design 정보
8. Study Design  
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 
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 
Cohort/
Group 2
Cohort/
Group Label
patient with malignant colorectal obstruction, air group 
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  
Subject Eligibility Information
9. Subject  
Study Population Description adult visiting Kyungpook National University Medical Center  
Sampling Method simple random sampling  
Condition(s)/Problem(s) * Neoplasms
malignant colorectal obstruction  
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
Outcome Measure(s) Information
10. Outcome Measure(s)  
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 
Study Results and Publication Information
11. Study Results and Publication
Result Registerd No
Sharing of Study Data Information
12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement No