CO2 Versus Air Insufflation for Single-balloon Enteroscopy

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT01758900
First received: December 18, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

Small-balloon enteroscopy(SBE) is a novel endoscopy system for examination of the deep small intestine.Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE examination, but it is still uncertain to the SBE procedure.


Condition Intervention Phase
Intubation Depth
Device: CO2 insufflation regulator
Device: Air insufflation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Official Title: CO2 Versus Air Insufflation for Single-balloon Enteroscopy: a Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Intubation depth [ Time Frame: Within 5 minutes after the examination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total enteroscopy rate [ Time Frame: Within 1 week after all the examinations are finished ] [ Designated as safety issue: No ]
  • Diagnostic rate [ Time Frame: Within 1 week after all the examinations are finished ] [ Designated as safety issue: No ]
  • Patient's acceptability [ Time Frame: 6 hours after the examination ] [ Designated as safety issue: No ]
  • Procedure time [ Time Frame: Within 5 minutes after the examination ] [ Designated as safety issue: No ]
  • Circumstances of bowel [ Time Frame: 10 minutes before/after the examination ] [ Designated as safety issue: No ]
  • Complication rate [ Time Frame: Within 1 week after all the examinations are finished ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 214
Study Start Date: July 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Air insufflation regulator
Room air will be used for insufflation as the Active Comparator arm
Device: Air insufflation
The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
Experimental: CO2 insufflation regulator
Device: CO2 insufflation regulator
Device: CO2 insufflation regulator
The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.

Detailed Description:

Currently, air is more frequently used to insufflate gas into the lumen to ensure the visualization of the mucosa. However, there're some limitations, for instance, significant amounts of air are usually retained in the small bowel, which will lead to the distention and the pain of the gastrointestinal tract during and after the procedure.

Carbon dioxide(CO2), comparing to the air, is rapidly absorbed from the intestine, which allows the bowel to decompress more quickly and potentially decreases intraprocedural and postprocedural pain, sedation medication requirements, procedure time, and recovery time. It is also to the benefit of deeper intubation depth so that higher total enteroscopy rate and diagnostic rate will be achieved.

Initial reports indicated that CO2 was effective during the colonoscopy ,ERCP and DBE examination, but it is still uncertain to the SBE procedure

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients referred for SBE at the trial centre

Exclusion Criteria:

  • Age under 18 years, over 75 years Refusal of participation GIST, apparent tumor, post surgery Crohn's disease, Intestinal obstruction, stenosis, radiation enteritis Severe cardiopulmonary dysfunction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01758900

Contacts
Contact: Zhizheng Ge, MD. Ph.D 18621890923 zhizhengge@yahoo.com.cn

Locations
China, Shanghai
Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Zhizheng Ge, MD. Ph.D    18621890923    zhizhengge@yahoo.com.cn   
Principal Investigator: Zhizheng Ge, MD. Ph.D         
Sponsors and Collaborators
Zhizheng Ge
Investigators
Principal Investigator: Zhizheng Ge, Ph.D. MD. Department of Gastroenterology, Renji Hospital, Shanghai Institute of Digestive Diseases, Shanghai Jiao Tong University School of Medicine Shanghai
  More Information

Publications:

Responsible Party: Zhizheng Ge, Shanghai Institute of Digestive Disease,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01758900     History of Changes
Other Study ID Numbers: rjer2011-70k
Study First Received: December 18, 2012
Last Updated: March 18, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Single-Balloon Enteroscopy

ClinicalTrials.gov processed this record on August 01, 2014