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Carbon dioxide insufflation during endoscopic colorectal stenting for malignant colorectal obstruction: a randomized controlled trial

Status Approved

  • First Submitted Date

    2018/11/06

  • Registered Date

    2019/01/11

  • Last Updated Date

    2018/12/05

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    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
    Institutional Review Board Address 807, Hoguk-ro, Buk-gu, Daegu
    Institutional Review Board Telephone 053-200-2162
    Data Monitoring Committee No

  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    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, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    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 Kyungpook National University Medical Center
    Recruitment Status Recruiting
    Date of First Enrollment 2018-05-08 ,

  • 5. Source of Monetary / Material Support

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

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    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 Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Prospective  
    Target Number of Participant 50
    Cohort/Group Number 2
    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
    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 
    		
												
    
											    
										
    
									
									
								
							
    
						
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  • 
							
    
								
    
									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)
											
												
												* (K00-K93)Diseases of the digestive system 
    
												
												
												   (K56.6)Other and unspecified intestinal obstruction 
												
												
												

    
												malignant colorectal obstruction
												
											    		
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Both
											    		
										
    
										
    
											
												
    Age
    
												18Year~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
												
											
										
    
									    
								
    
							
    
						
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  • 
							
    
								
    
									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												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
    		
											
    
										
									    
								
    
							
    
						
    • 
						
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									11. Study Results and Publication
								
    
								
							
    
							
    
								
    
									Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
									
										
    
											Result Registered
											
												
													
													No
												
												
												
											
										
    
										
									    
								
    
							
    
						
    • 
						
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									12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
								
    
								
							
    
							
    
								
    
									Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
									
										
    
											Sharing Statement
											
												
													
													No
													
												
											
										
    
										
									    
								
    
							
    
						
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