CO2 vs. Air Insufflation for Endoscopic Ultrasound

April 7, 2017 updated by: Pietro Fusaroli, University of Bologna

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Imola (BO), Italy, 40026
        • Gastrointestinal Unit, University of Bologna/Hospital of Imola

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with indications for undergoing EUS (in general they are represented by patients with pancreaticobiliary or gastrointestinal diseases)

Description

Inclusion Criteria:

• Consecutive patients referred for EUS

Exclusion Criteria:

  • Age <18
  • Pregnancy
  • Unwillingness to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EUS with CO2 insufflation
Patients undergoing EUS with CO2 insufflation
Other: EUS with CO2 insufflation
Diagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using CO2 insufflation
EUS with air insufflation
Patients undergoing EUS with air insufflation
Other: EUS with air insufflation
Diagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using air insufflation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dose of sedation
Time Frame: through study completion, an average of 1 year
Measured by the physician after endoscopic ultrasound
through study completion, an average of 1 year
Quality of EUS images
Time Frame: through study completion, an average of 1 year
Evaluation of the quality of EUS images by several physicians
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bologna

Investigators

  • Principal Investigator: Pietro Fusaroli, MD, Department of Medical and Surgical Sciences, GI Unit, University of Bologna/Hospital of Imola, Imola, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 12, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 10, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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