CholestasisNCT00685386
A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)
A study testing CO2 insufflation and Room air insufflation in people with Cholestasis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholestasis
- What is being tested?
- CO2 insufflation and Room air insufflation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Feb 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18 years
- referred for ERCP for any indication at UNC Hospitals
Who cannot join
- age < 18 years
- COPD requiring oxygen or with known CO2 retention
- any medical condition with known CO2 retention
- medical instability making the procedure unsafe
- absolute requirement for same-day second endoscopy
- ERCP performed in the OR or under GA
Show all 9Show fewer
- inability to read or understand English
- use of chronic opiates for pain
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography
The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).
- Conditions
- Cholestasis
- Being tested
- CO2 insufflation, Room air insufflation
- Keywords
- endoscopic retrograde cholangiopancreatography, carbon dioxide, randomized controlled clinical trial
- Medical subject headings
- Cholestasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CO2 insufflationOther
Also called Olympus XUCR manufacured by Olympus Medical.
The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).
Room air insufflationOther
During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Not described Receives: Other: CO2 insufflation |
| II | Placebo comparator | Room air will be used for insufflation as the placebo comparator arm. Receives: Other: Room air insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain (VAS).
Measured: pre-procedure and up to 24 hours post-procedure.
Secondary outcomes (1)
The extent of CO2 retention.
Measured: Intra-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startJun 2008
- Primary completionJan 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CholestasisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Olympic Medical, National Institutes of Health (NIH)
- Investigators
- Evan S. Dellon, MD MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685386
- Sponsor's protocol ID
- 07-1404
- Status last verified
- Apr 2011
- First submitted
- 23 May 2008
- Last updated
- 24 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dellon ES, Velayudham A, Clarke BW, Isaacs KL, Gangarosa LM, Galanko JA, Grimm IS. A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP. Gastrointest Endosc. 2010 Jul;72(1):68-77. doi: 10.1016/j.gie.2010.01.041. Epub 2010 May 20.
PubMed 20493485
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT00685386
- Acronym / sponsor ID
- 07-1404
- Conditions
- Cholestasis
- Keywords
- endoscopic retrograde cholangiopancreatography, carbon dioxide, randomized controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Olympic Medical, National Institutes of Health (NIH)
- Study start
- Jun 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 28 May 2008 (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 purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Other: CO2 insufflation |
| II | Placebo comparator | Other: Room air insufflationRoom air will be used for insufflation as the placebo comparator arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age >= 18 years
- referred for ERCP for any indication at UNC Hospitals
Key exclusion criteria (9 listed)
- age < 18 years
- COPD requiring oxygen or with known CO2 retention
- any medical condition with known CO2 retention
- medical instability making the procedure unsafe
- absolute requirement for same-day second endoscopy
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 |
|---|---|---|
| CO2 insufflationAlso: Olympus XUCR manufacured by Olympus Medical.The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air). | Other | I |
| Room air insufflationDuring the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator. | Other | II |
Primary outcome
Abdominal pain (VAS).
Time frame: pre-procedure and up to 24 hours post-procedure.
1 secondary outcome
The extent of CO2 retention.
Time frame: Intra-procedure
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 24 Jan 2013.
- Derived from this study: PubMed 20493485Dellon ES, Velayudham A, Clarke BW, Isaacs KL, Gangarosa LM, Galanko JA, Grimm IS. A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP. Gastrointest Endosc. 2010 Jul;72(1):68-77. doi: 10.1016/j.gie.2010.01.041. Epub 2010 May 20.
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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.
Evan S. Dellon, MD MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CO2 insufflation and Room air insufflation in people with Cholestasis, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 2 inclusion and 9 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 24 Jan 2013. 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 United States. 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. Some participants in this study may receive a placebo. 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 pain (VAS). (time frame: pre-procedure and up to 24 hours post-procedure.). 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 NCT00685386, which also lists 1 linked publication.
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 24 Jan 2013.