Lesion; Gastrointestinal Clinical Trial
Official title:
Role of CO2 Insufflation vs. Air Insufflation for Endoscopic Ultrasound: a Prospective Observational Study
| Verified date | April 2017 |
| Source | University of Bologna |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
The insufflation of air in the viscera is indispensable during endoscopy. However, the
distension of the bowel that follows is often the cause of abdominal discomfort.
Carbon dioxide (CO2) has been widely used for insufflation in endoscopy. CO2 insufflation is
demonstrated in the literature to cause lower abdominal discomfort as it is quickly
reabsorbed by the body.
Endoscopic ultrasonography (EUS) is a method in which you associate the endoscopic view and
the ultrasound vision obtained from the inside of the viscera.
The diagnostic accuracy of EUS is undermined by the visual artifacts caused by the presence
of air between the probe and the organ to be studied.
Although the use of CO2 is already widely applied by many endoscopists, there are no studies
to date concerning the use of CO2 during EUS from the point of view of the abdominal
discomfort related to the procedure and/or the quality of the images obtained.
The main purpose of the study is to assess whether the insufflation of CO2 results in a
reduction of discomfort of the patients undergoing EUS. The study design is observational
because no randomization or other interventions are planned; participants will be assigned
to either air or CO2 insufflation according to the endoscopic room equipment (one room is
equipped with CO2 insufflation while another endoscopic room is equipped just with air
insufflation) and the results of the two groups will be compared. Among the secondary goals
the investigators want to evaluate whether insufflation of CO2 is associated with a
reduction in the dose required for patients sedation. Finally, the investigators want to
clarify whether the use of CO2 is able to produce less visual artifacts than air and thus
improve the quality of EUS images.
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | April 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
Inclusion Criteria: • Consecutive patients referred for EUS Exclusion Criteria: - Age <18 - Pregnancy - Unwillingness to participate |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Gastrointestinal Unit, University of Bologna/Hospital of Imola | Imola (BO) |
| Lead Sponsor | Collaborator |
|---|---|
| University of Bologna |
Italy,
Bretthauer M, Lynge AB, Thiis-Evensen E, Hoff G, Fausa O, Aabakken L. Carbon dioxide insufflation in colonoscopy: safe and effective in sedated patients. Endoscopy. 2005 Aug;37(8):706-9. — View Citation
Li X, Zhao YJ, Dai J, Li XB, Xue HB, Zhang Y, Xiong GS, Ohtsuka K, Gao YJ, Liu Q, Song Y, Fang JY, Ge ZZ. Carbon dioxide insufflation improves the intubation depth and total enteroscopy rate in single-balloon enteroscopy: a randomised, controlled, double-blind trial. Gut. 2014 Oct;63(10):1560-5. doi: 10.1136/gutjnl-2013-306069. Epub 2014 Mar 13. — View Citation
Wu J, Hu B. The role of carbon dioxide insufflation in colonoscopy: a systematic review and meta-analysis. Endoscopy. 2012 Feb;44(2):128-36. doi: 10.1055/s-0031-1291487. Epub 2012 Jan 23. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Abdominal discomfort | Self reported pain measurement after endoscopic ultrasound assessed with a Visual Analog Scale (VAS 0-10) | through study completion, an average of 1 year | |
| Secondary | Dose of sedation | Measured by the physician after endoscopic ultrasound | through study completion, an average of 1 year | |
| Secondary | Quality of EUS images | Evaluation of the quality of EUS images by several physicians | through study completion, an average of 1 year |