Lower Esophageal RingPhase 2/3NCT00204750
Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
A Phase 2/3 study testing Bougie Dilation and Needle-knife incision in people with Lower Esophageal Ring and Dysphagia, run by University of Utah at 1 site in United States.
Trial summary
The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Esophageal Ring, Dysphagia
- What is being tested?
- Bougie Dilation and Needle-knife incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Dec 2006
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 18-80 with symptomatic Schatzki's ring
- No history of bleeding diathesis or other contraindication to bougie dilation or electrosurgical incision
Who cannot join
- Contraindication to proton pump inhibitors
- Pregnancy
- Inability to provide informed consent
- History of previous esophagogastric surgery
- Presence of esophageal peptic stricture, esophageal motility disorder or esophageal cancer that could otherwise account for dysphagia
- Nasopharyngeal lesion or nasal intubation intolerance causing inability to undergo esophageal motility testing and ambulatory pH monitoring
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings
The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. All patients will be followed for one year for recurrence and/or severity of dysphagia and will be placed on rabeprazole for that time period.
Read the detailed description
Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at endoscopy, the patient will be randomized to electrosurgical incision or standard bougie dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months).
- Conditions
- Lower Esophageal Ring, Dysphagia
- Being tested
- Bougie Dilation, Needle-knife incision
- Keywords
- lower esophageal ring, dysphagia, electrosurgical incision, bougie dilation, GERD
- Medical subject headings
- Esophageal Ring, Lower, Deglutition Disorders, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bougie DilationProcedure or surgery
Also called Maloney dilation
Bougie dilation will be performed as standard
Needle-knife incisionProcedure or surgery
Needle-knife incision will be performed
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Bougie dilation Receives: Procedure: Bougie Dilation |
| 2 | Experimental | Needle-knife incision Receives: Procedure: Needle-knife incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence at one year of Schatzki's ring
Measured: One year
Secondary outcomes (2)
GERD score at 1,3,6,9,12 month time intervals
Measured: one year
Dysphagia score at 1,3,6,9,12 month time intervals
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 posted20 Sep 2005 (estimated)
- Study startAug 2001
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Esophageal RingStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Investigators
- John Fang, M.D., Study director, University of Utah HSCJames A DiSario, M.D., Principal investigator, University of Utah HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00204750
- Sponsor's protocol ID
- 8953
- Status last verified
- Dec 2007
- First submitted
- 12 Sep 2005
- Last updated
- 4 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings
- ClinicalTrials.gov ID
- NCT00204750
- Acronym / sponsor ID
- 8953
- Conditions
- Lower Esophageal Ring, Dysphagia
- Keywords
- lower esophageal ring, dysphagia, electrosurgical incision, bougie dilation, GERD
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- PriCara, Unit of Ortho-McNeil, Inc.
- Study start
- Aug 2001
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 20 Sep 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.
The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. All patients will be followed for one year for recurrence and/or severity of dysphagia and will be placed on rabeprazole for that time period.
Detailed description
Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at endoscopy, the patient will be randomized to electrosurgical incision or standard bougie dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Bougie DilationBougie dilation |
| 2 | Experimental | Procedure: Needle-knife incisionNeedle-knife incision |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between the ages of 18-80 with symptomatic Schatzki's ring
- No history of bleeding diathesis or other contraindication to bougie dilation or electrosurgical incision
Key exclusion criteria (6 listed)
- Contraindication to proton pump inhibitors
- Pregnancy
- Inability to provide informed consent
- History of previous esophagogastric surgery
- Presence of esophageal peptic stricture, esophageal motility disorder or esophageal cancer that could otherwise account for dysphagia
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 |
|---|---|---|
| Bougie DilationAlso: Maloney dilationBougie dilation will be performed as standard | Procedure or surgery | 1 |
| Needle-knife incisionNeedle-knife incision will be performed | Procedure or surgery | 2 |
Primary outcome
Recurrence at one year of Schatzki's ring
Time frame: One year
2 secondary outcomes
GERD score at 1,3,6,9,12 month time intervals
Time frame: one year
Dysphagia score at 1,3,6,9,12 month time intervals
Time frame: one 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 4 Jan 2008.
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.
John Fang, M.D. study director
University of Utah HSC
James A DiSario, M.D. principal investigator
University of Utah HSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bougie Dilation and Needle-knife incision in people with Lower Esophageal Ring and Dysphagia, run by University of Utah 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 6 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 4 Jan 2008. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Recurrence at one year of Schatzki's ring (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 Jan 2008.