Lesion; GastrointestinalNCT02773563
CO2 vs. Air Insufflation for Endoscopic Ultrasound
An observational study of Lesion; Gastrointestinal and Liver, Biliary, Pancreas and Gastrointestinal Disease, Nos, run by University of Bologna at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Lesion; Gastrointestinal, Liver, Biliary, Pancreas and Gastrointestinal Disease, Nos
- What is being tested?
- EUS with air insufflation and EUS with CO2 insufflation
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2016to Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indications for undergoing EUS (in general they are represented by patients with pancreaticobiliary or gastrointestinal diseases)
Who may be able to join
- Consecutive patients referred for EUS
Who cannot join
- Age <18
- Pregnancy
- Unwillingness to participate
Trial locations and contacts
1 site in 1 country.
Italy1 site
Gastrointestinal Unit, University of Bologna/Hospital of Imola
Imola (BO), Italy, 40026
About this study
Official title: Role of CO2 Insufflation vs. Air Insufflation for Endoscopic Ultrasound: a Prospective Observational Study
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.
Read more
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.
Read the detailed description
The insufflation of air in the viscera during endoscopy is indispensable in order to allow the advancement of endoscopic probe, to visualize the mucosa and to avoid injury to the gastrointestinal wall. However, the distension of the bowel that follows is often the cause of abdominal discomfort since the air blown appears to be slightly absorbable and therefore it needs a long time to be expelled.
Carbon dioxide (CO2) is a gas that has already 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. This gas is at the same time devoid of side effects.
Studies in the literature focus mainly on the intensity of abdominal discomfort after the insufflation of CO2 vs. air while performing colonoscopy, endoscopic retrograde cholangiopancreatography (ERCP) and enteroscopy.
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 main indications to EUS are represented by the study of the biliary pancreatic diseases, the staging of the digestive tract tumors and the differential diagnosis of submucosal tumors.
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; during the procedure the endoscopist must ensure, by means of repeated suctions, that the least possible amount of air is present inside the viscera.
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.
At the moment, with regard to EUS, there are no recommendations regarding the use of a gas rather than the other; the choice is in fact at the discretion of the operator and also it depends on the availability in the individual endoscopic units of the instrumentation for CO2 insufflation.
At Our Endoscopic Unit, CO2 or air insufflation is decided upon the availability of the equipment in the endoscopic room; in particular, in Suite 1, patients receive air insufflation and in Suite 2 they receive CO2 insufflation. The assignment into one or the other endoscopic room is purely casual according to scheduling the next free available slot.
The main purpose of the study is to assess whether there is any difference between CO2 and air insufflation in inducing discomfort of the patients undergoing EUS. The study design is observational because no randomization or other intervention modifications 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.
- Being tested
- EUS with air insufflation, EUS with CO2 insufflation
- Medical subject headings
- Gastrointestinal Diseases, Pyloric Stenosis, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS with air insufflationOther
Diagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using air insufflation
EUS with CO2 insufflationOther
Diagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using CO2 insufflation
| Study group | Role | What they receive |
|---|---|---|
| EUS with CO2 insufflation | Patients undergoing EUS with CO2 insufflation Receives: Other: EUS with CO2 insufflation | |
| EUS with air insufflation | Patients undergoing EUS with air insufflation Receives: Other: EUS with air insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal discomfort
Self reported pain measurement after endoscopic ultrasound assessed with a Visual Analog Scale (VAS 0-10)
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Dose of sedation
Measured by the physician after endoscopic ultrasound
Measured: through study completion, an average of 1 year
Quality of EUS images
Evaluation of the quality of EUS images by several physicians
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study startApr 2016
- Primary completionMar 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lesion; GastrointestinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pietro Fusaroli, University of Bologna
- Investigators
- Pietro Fusaroli, MD, Principal investigator, Department of Medical and Surgical Sciences, GI Unit, University of Bologna/Hospital of Imola, Imola, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773563
- Sponsor's protocol ID
- 2016/001
- Status last verified
- Apr 2017
- First submitted
- 12 May 2016
- Last updated
- 10 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 22271023Bretthauer 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. doi: 10.1055/s-2005-870154.
PubMed 16032487Li 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.
PubMed 24626435
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of CO2 Insufflation vs. Air Insufflation for Endoscopic Ultrasound: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02773563
- Acronym / sponsor ID
- 2016/001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The insufflation of air in the viscera during endoscopy is indispensable in order to allow the advancement of endoscopic probe, to visualize the mucosa and to avoid injury to the gastrointestinal wall. However, the distension of the bowel that follows is often the cause of abdominal discomfort since the air blown appears to be slightly absorbable and therefore it needs a long time to be expelled.
Carbon dioxide (CO2) is a gas that has already 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. This gas is at the same time devoid of side effects.
Studies in the literature focus mainly on the intensity of abdominal discomfort after the insufflation of CO2 vs. air while performing colonoscopy, endoscopic retrograde cholangiopancreatography (ERCP) and enteroscopy.
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 main indications to EUS are represented by the study of the biliary pancreatic diseases, the staging of the digestive tract tumors and the differential diagnosis of submucosal tumors.
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; during the procedure the endoscopist must ensure, by means of repeated suctions, that the least possible amount of air is present inside the viscera.
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.
At the moment, with regard to EUS, there are no recommendations regarding the use of a gas rather than the other; the choice is in fact at the discretion of the operator and also it depends on the availability in the individual endoscopic units of the instrumentation for CO2 insufflation.
At Our Endoscopic Unit, CO2 or air insufflation is decided upon the availability of the equipment in the endoscopic room; in particular, in Suite 1, patients receive air insufflation and in Suite 2 they receive CO2 insufflation. The assignment into one or the other endoscopic room is purely casual according to scheduling the next free available slot.
The main purpose of the study is to assess whether there is any difference between CO2 and air insufflation in inducing discomfort of the patients undergoing EUS. The study design is observational because no randomization or other intervention modifications 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS with CO2 insufflation | – | Other: EUS with CO2 insufflationPatients undergoing EUS with CO2 insufflation |
| EUS with air insufflation | – | Other: EUS with air insufflationPatients undergoing EUS with air insufflation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indications for undergoing EUS (in general they are represented by patients with pancreaticobiliary or gastrointestinal diseases)
Key inclusion criteria (1 listed)
- Consecutive patients referred for EUS
Key exclusion criteria (3 listed)
- Age <18
- Pregnancy
- Unwillingness to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EUS with air insufflationDiagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using air insufflation | Other | EUS with air insufflation |
| EUS with CO2 insufflationDiagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using CO2 insufflation | Other | EUS with CO2 insufflation |
Primary outcome
Abdominal discomfort
Time frame: through study completion, an average of 1 year
Self reported pain measurement after endoscopic ultrasound assessed with a Visual Analog Scale (VAS 0-10)
2 secondary outcomes
Dose of sedation
Time frame: through study completion, an average of 1 year
Quality of EUS images
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2017.
- Background: PubMed 22271023Wu 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.
- Background: PubMed 16032487Bretthauer 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. doi: 10.1055/s-2005-870154.
- Background: PubMed 24626435Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pietro Fusaroli, MD principal investigator
Department of Medical and Surgical Sciences, GI Unit, University of Bologna/Hospital of Imola, Imola, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lesion; Gastrointestinal and Liver, Biliary, Pancreas and Gastrointestinal Disease, Nos, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal discomfort (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02773563, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2017.