Sphincter of Oddi DysfunctionNCT01410071
Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction
An observational study of Sphincter of Oddi Dysfunction and Abdominal Pain, run by Wisconsin Center for Advanced Research at 1 site in United States.
Trial summary
The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sphincter of Oddi Dysfunction, Abdominal Pain
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Aug 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: physician's private practice/clinic patients presenting with suspected sphincter of oddi dysfunction
Who may be able to join
- over age 18
- suspected history and clinical features suggestive of sphincter of oddi dysfunction
Who cannot join
- prior history of endoscopic therapy for sphincter of oddi dysfunction
- no proven sphincter of oddi dysfunction on manometry
Trial locations and contacts
1 site in 1 country.
United States1 site
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53151
About this study
Official title: Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction: Evaluation of the Differences Between Those Undergoing Endoscopic Therapy vs.Conservative Care
The purpose of this research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.
Read the detailed description
Sphincter of Oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. Resting pressures >40mm of Hg are considered abnormal. Individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. Sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. In most instances the pain is debilitating and could impair the quality of life. Endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. Data regarding the efficacy of such an approach are limited. A recent systematic review by the Cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of Oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.
- Conditions
- Sphincter of Oddi Dysfunction, Abdominal Pain
- Keywords
- Sphincter of Oddi Dysfunction
- Medical subject headings
- Sphincter of Oddi Dysfunction, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sphincter of oddi dysfunction | endoscopic therapy vs conservative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom improvement
Measured: one year
Secondary outcomes (1)
improved quality of life
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2011 (estimated)
- Study startSep 2005
- Primary completionJun 2009
- Study completionAug 2009
Why it stopped: Analysis of designed comparison groups not viable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sphincter of Oddi DysfunctionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wisconsin Center for Advanced Research
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Investigators
- Nalini M Guda, MD, Principal investigator, GI Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01410071
- Sponsor's protocol ID
- S-05-130E
- Status last verified
- Aug 2011
- First submitted
- 2 Aug 2011
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Gastrointestinal Symptoms and Quality of Life in Patients With Sphincter of Oddi Dysfunction: Evaluation of the Differences Between Those Undergoing Endoscopic Therapy vs.Conservative Care
- ClinicalTrials.gov ID
- NCT01410071
- Acronym / sponsor ID
- S-05-130E
- Conditions
- Sphincter of Oddi Dysfunction, Abdominal Pain
- Keywords
- Sphincter of Oddi Dysfunction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Analysis of designed comparison groups not viable
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Wisconsin Center for Advanced ResearchUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences
- Study start
- Sep 2005
- Primary completion
- Jun 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 4 Aug 2011 (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 research study is to see if there is a significant difference in improvement of symptoms and quality of life of those undergoing endoscopic therapy versus those wanting to control their symptoms with medicines or those who just want to wait and watch.
Detailed description
Sphincter of Oddi is a complex muscular structure which regulates the biliary and pancreatic outflow into the duodenum. Resting pressures >40mm of Hg are considered abnormal. Individuals with elevated resting/basal biliary or pancreatic sphincter pressures are thought to have sphincter of oddi dysfunction. Sphincter dysfunction often manifests as pain and the nature of the pain is dependent on the involvement of either the biliary or the pancreatic sphincter. In most instances the pain is debilitating and could impair the quality of life. Endoscopic therapy- either biliary or pancreatic sphincterotomy, is often performed for relief of symptoms. Data regarding the efficacy of such an approach are limited. A recent systematic review by the Cochrane reviewers has found only two randomized controlled trials evaluating the efficacy of sphincterotomy for relief of symptoms in those with sphincter of Oddi dysfunction and there were no data evaluating the quality of life or the health economics of such an approach.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sphincter of oddi dysfunction | – | –endoscopic therapy vs conservative care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- physician's private practice/clinic patients presenting with suspected sphincter of oddi dysfunction
Key inclusion criteria (2 listed)
- over age 18
- suspected history and clinical features suggestive of sphincter of oddi dysfunction
Key exclusion criteria (2 listed)
- prior history of endoscopic therapy for sphincter of oddi dysfunction
- no proven sphincter of oddi dysfunction on manometry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
symptom improvement
Time frame: one year
1 secondary outcome
improved quality of life
Time frame: one year
Results and safety
The study was stopped early (reason given: Analysis of designed comparison groups not viable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
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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.
Nalini M Guda, MD principal investigator
GI Associates
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 Sphincter of Oddi Dysfunction and Abdominal Pain, run by Wisconsin Center for Advanced Research 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 2 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: stopped early, as of the sponsor's last update on 4 Aug 2011. 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. 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 was stopped early (reason given: Analysis of designed comparison groups not viable). Results are not available in the source record.
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?
symptom improvement (time frame: one year). 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 4 Aug 2011.