Biliary Tract DiseasePhase 1/2NCT00124202
Effect of a Fatty Meal on Endoscopic Retrograde Cholangiopancreatography (ERCP)
A Phase 1/2 study testing a fatty meal in people with Biliary Tract Disease, run by Emory University at 1 site in United States.
Trial summary
This study is to determine if a fatty meal would improve the ERCP procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Disease
- What is being tested?
- a fatty meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to May 2007
- Phase
- Phase 1/2
- 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
- Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure.
Who cannot join
- Patients with a known allergy to milk or those who choose not to sign the consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory University School of Medicine; Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography
This study is to determine if a fatty meal would improve the ERCP procedure.
Read the detailed description
A fatty meal is a potent stimulator of cholecystikinin (CCK) in human body. The biological effect of CCK is increasing bile secretion and relaxing the sphincter of Oddi. Theoretically, a fatty meal should facilitate the effect on cannulation at ERCP. If a fatty meal can make the major papilla cannulation easier, it may significantly shorten the procedure time for ERCP and even decrease complications of the procedure, since the complication rate of post-ERCP is positively related to the time of the procedure.
Comparison: Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group.
- Conditions
- Biliary Tract Disease
- Being tested
- a fatty meal
- Keywords
- a fatty meal, ERCP
- Medical subject headings
- Biliary Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a fatty mealBehavioural
Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group
| Study group | Role | What they receive |
|---|---|---|
| a fatty meal vs normal saline | Placebo comparator | Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group Receives: Behavioral: a fatty meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
a fatty meal in the study group and normal saline in control group
Measured: the procedure time for ERCP
Secondary outcomes (1)
follow up within 3 days for complication with relation to the cannulation time
Measured: within 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2005 (estimated)
- Study startMay 2003
- Primary completionDec 2004
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Qiang Cai MD/PhD, Emory University
- Investigators
- Qiang Cai, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124202
- Sponsor's protocol ID
- 229-2003
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2005
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Fatty Meal on Cannulation at Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT00124202
- Acronym / sponsor ID
- 229-2003
- Conditions
- Biliary Tract Disease
- Keywords
- a fatty meal, ERCP
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- May 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 27 Jul 2005 (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.
This study is to determine if a fatty meal would improve the ERCP procedure.
Detailed description
A fatty meal is a potent stimulator of cholecystikinin (CCK) in human body. The biological effect of CCK is increasing bile secretion and relaxing the sphincter of Oddi. Theoretically, a fatty meal should facilitate the effect on cannulation at ERCP. If a fatty meal can make the major papilla cannulation easier, it may significantly shorten the procedure time for ERCP and even decrease complications of the procedure, since the complication rate of post-ERCP is positively related to the time of the procedure.
Comparison: Approximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| a fatty meal vs normal saline | Placebo comparator | Behavioral: a fatty mealApproximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients, 18 years and older, who are scheduled for ERCP at Emory University Hospital and signed consent before the procedure.
Key exclusion criteria (1 listed)
- Patients with a known allergy to milk or those who choose not to sign the consent.
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 |
|---|---|---|
| a fatty mealApproximately one hour before ERCP procedure, patient will have a fatty meal in the study group and normal saline in control group | Behavioural | a fatty meal vs normal saline |
Primary outcome
a fatty meal in the study group and normal saline in control group
Time frame: the procedure time for ERCP
1 secondary outcome
follow up within 3 days for complication with relation to the cannulation time
Time frame: within 3 days
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 31 Jul 2013.
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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.
Qiang Cai, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing a fatty meal in people with Biliary Tract Disease, run by Emory University 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 1 inclusion and 1 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 31 Jul 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
a fatty meal in the study group and normal saline in control group (time frame: the procedure time for ERCP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2013; AzTrials last refreshed its copy on 8 Nov 2026.