Esophageal AchalasiaNCT02606578
Achalasia Patient Reported Outcomes
An observational study of Esophageal Achalasia and Achalasia, run by Mayo Clinic at 1 site in United States.
Trial summary
Patients that are either scheduled to undergo or have undergone an achalasia procedure at the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather information and determine if one of these procedures is superior to the other. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Esophageal Achalasia, Achalasia, Achalasia, Esophageal
- What is being tested?
- Questionnaires
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 15 Jan 2021
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing PerOral Endoscopic Myotomy (POEM) or Laparoscopic Modified Heller Myotomy and Anti-Reflux Procedures at Mayo Clinic Rochester
Who may be able to join
- >18 years old
- Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures
- Esophagus diameter less <8 cm on barium swallow test
Who cannot join
- Pregnant
- Diverticular disease of the esophagus
- Barrett's esophagus
- Extensive abdominal adhesions
- <50% predicted FEV1 on pulmonary function testing
- Cardiac ejection fraction <25%
Show all 9Show fewer
- Esophageal stricture from prior myotomy
- Sigmoidization of the esophagus
- More than one prior balloon dilation (>3 cm) or any prior dilation of 3 cm
Trial locations and contacts
1 site in 1 country.
About this study
Patients that are either scheduled to undergo or have undergone an achalasia procedure at the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather information and determine if one of these procedures is superior to the other.
Read the detailed description
This is a non-randomized, non-inferiority trial that has been created to compare results of achalasia procedures including but not limited to: POEM + Partial Fundoplication (PF), POEM and Laparoscopic Modified Heller Myotomy + PF and POEM + Peroral Plication of the esophagus. Using a set of consistent evaluation tools for patients undergoing treatment for achalasia allows a standardized evaluation and comparison of these groups of patients. The long term and comparative POEM procedure outcomes are not currently known. Patients undergoing POEM, fundoplication, and/or laparoscopic myotomy report having varying degrees of symptoms of reflux, dysphagia, and pain. Providers also note varying degrees of esophagitis by endoscopy, reflux by impedance or pH scoring, and recurrence by repeat manometry. Many of these issues can be quantified using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, Endoflip device and esophagrams. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Ekhardt Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's postoperative outcome.
- Conditions
- Esophageal Achalasia, Achalasia, Achalasia, Esophageal
- Being tested
- Questionnaires
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
The study team will collect information from your medical record regarding: demographics, operation, nutritional status, laboratory values, testing results, complications, hospital data, cost, length of stay, past medical history and clinical outcomes.
At your clinical follow-up visits (~4 weeks, 6 months, and 12 months post operation), a study coordinator will meet with you to assess for adverse events and to have you complete research questionnaires. Alternatively, the study coordinator may call you to assess for adverse events and ask if we can mail you the research questionnaires to complete and mail back.
You will also be asked to complete the research questionnaires a minimum of once a year for your lifetime: A study coordinator will call you and ask if we can mail you questionnaires to complete and mail back.
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire
Comparison of surgical techniques evaluated from the patient's medical record using patient reported post-operative symptoms on the achalasia questionnaire. The achalasia questionnaire includes quality of life, pain, activity level, heart burn, acid regurgitation, reflux, dysphagia, and diet.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startOct 2015
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Why it stopped: Study's original Principal Investigator no longer at the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AchalasiaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janani S. Reisenauer, Mayo Clinic
- Investigators
- Janani Reisenauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02606578
- Sponsor's protocol ID
- 15-006921
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2015
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achalasia Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT02606578
- Acronym / sponsor ID
- 15-006921
- Conditions
- Esophageal Achalasia, Achalasia, Achalasia, Esophageal
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study's original Principal Investigator no longer at the institution.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 17 Nov 2015 (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.
Patients that are either scheduled to undergo or have undergone an achalasia procedure at the Mayo Clinic Rochester are asked to participate. The purpose of this study is to gather information and determine if one of these procedures is superior to the other.
Detailed description
This is a non-randomized, non-inferiority trial that has been created to compare results of achalasia procedures including but not limited to: POEM + Partial Fundoplication (PF), POEM and Laparoscopic Modified Heller Myotomy + PF and POEM + Peroral Plication of the esophagus. Using a set of consistent evaluation tools for patients undergoing treatment for achalasia allows a standardized evaluation and comparison of these groups of patients. The long term and comparative POEM procedure outcomes are not currently known. Patients undergoing POEM, fundoplication, and/or laparoscopic myotomy report having varying degrees of symptoms of reflux, dysphagia, and pain. Providers also note varying degrees of esophagitis by endoscopy, reflux by impedance or pH scoring, and recurrence by repeat manometry. Many of these issues can be quantified using pH probe testing, upper GI endoscopy, high resolution manometry, CT scans, Endoflip device and esophagrams. There are various validated questionnaires that have been used to assess problem areas of reflux, dysphagia, and pain such as the Promis Global Health Score, Ekhardt Score, Mayo GER Score, Modified Dysphagia Questionnaire-30 Day, Zubrod Score, and pain scale. Each of these symptoms, tests, and questionnaires contributes to the provider's understanding of the patient's postoperative outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing PerOral Endoscopic Myotomy (POEM) or Laparoscopic Modified Heller Myotomy and Anti-Reflux Procedures at Mayo Clinic Rochester
Key inclusion criteria (3 listed)
- >18 years old
- Undergoing a POEM or laparoscopic modified heller myotomy and anti-reflux procedures
- Esophagus diameter less <8 cm on barium swallow test
Key exclusion criteria (9 listed)
- Pregnant
- Diverticular disease of the esophagus
- Barrett's esophagus
- Extensive abdominal adhesions
- <50% predicted FEV1 on pulmonary function testing
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 |
|---|---|---|
| QuestionnairesThe study team will collect information from your medical record regarding: demographics, operation, nutritional status, laboratory values, testing results, complications, hospital data, cost, length of stay, past medical history and clinical outcomes. At your clinical follow-up visits (~4 weeks, 6 months, and 12 months post operation), a study coordinator will meet with you to assess for adverse events and to have you complete research questionnaires. Alternatively, the study coordinator may call you to assess for adverse events and ask if we can mail you the research questionnaires to complete and mail back. You will also be asked to complete the research questionnaires a minimum of once a year for your lifetime: A study coordinator will call you and ask if we can mail you questionnaires to complete and mail back. | Other | – |
Primary outcome
Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire
Time frame: 2 years
Comparison of surgical techniques evaluated from the patient's medical record using patient reported post-operative symptoms on the achalasia questionnaire. The achalasia questionnaire includes quality of life, pain, activity level, heart burn, acid regurgitation, reflux, dysphagia, and diet.
Results and safety
The study was stopped early (reason given: Study's original Principal Investigator no longer at the institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Achalasia
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.
Janani Reisenauer, MD principal investigator
Mayo Clinic
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 Esophageal Achalasia and Achalasia, run by Mayo Clinic 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 3 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: stopped early, as of the sponsor's last update on 22 Mar 2024. 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: Study's original Principal Investigator no longer at the institution.). 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?
Comparison of different surgical techniques with patient reported post-operative symptoms on the achalasia questionnaire (time frame: 2 years). 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 22 Mar 2024.