AchalasiaNCT04052581
Prospective Collection of Outcome Data Post POEM-TIF Procedure
An observational study of Achalasia and Gastroesophageal Reflux Disease, run by Johns Hopkins University.
Trial summary
Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia, Gastroesophageal Reflux Disease
- What is being tested?
- POEM-TIF
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2023to 26 Jul 2023
- 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: Adult patient age > 18 years old who have been diagnosis with either type I or type II Achalasia that has been proved by manometry
Who may be able to join
- Adult patient age greater than 18 years old
- Manometrically proven diagnosis of either type I or type II achalasia.
Who cannot join
- Achalasia type III, or other esophageal dysmotility disorders.
- Completion of POEM with evidence of mucosal injury or compromise
- Previous surgery of the stomach such as sleeve gastrectomy, gastric bypass, Heller myotomy, partial or complete fundoplication, or partial/complete gastrectomy
- Esophageal lumen diameter greater than 4 cm
- Sigmoidization of the esophagus
- Large esophageal diverticula
Show all 12Show fewer
- Known active gastroesophageal malignancy
- Inability to tolerate sedated upper endoscopy due to cardiopulmonary instability, severe pulmonary disease or other contraindication to endoscopy
- Cirrhosis with portal hypertension, varices, and/or ascites
- Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)
- Acute gastrointestinal bleeding
- Uncorrectable coagulopathy defined by international normalized ratio (INR) > 1.5 or platelet < 50,000
About this study
Official title: Assessment of Safety and Outcomes in Patients Undergoing a Standard-of-care Combined POEM-TIF Procedure
Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Recently, combined POEM-TIF has been performed successfully as a standard of care treatment for patients with severe GER after POEM. We aim to study the safety and feasibility of performing POEM-TIF (POEM and TIF in the same endoscopic session). This study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the POEM-TIF procedure.
- Conditions
- Achalasia, Gastroesophageal Reflux Disease
- Being tested
- POEM-TIF
- Keywords
- Per oral Endoscopic Myotomy, Transoral Incisionless Fundoplication, POEM, TIF
- Medical subject headings
- Esophageal Achalasia, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POEM-TIFProcedure or surgery
Transoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session
| Study group | Role | What they receive |
|---|---|---|
| POEM-TIF | All participants will undergo the POEM-TIF in the same session. Receives: Procedure: POEM-TIF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system
Safety will be evaluated by the frequency of severe adverse events with probable or definite attribution to the procedure based the ASGE lexicon scoring system. ASGE lexicon's severity grading system classify the adverse events into one of the four categories of mild, moderate, severe, and fatal. Mild adverse event means an adverse event that result in (1) Procedure aborted (or not started) because of an adverse event, (2) Post-procedure medical consultation, or (3) Unplanned hospital admission or prolongation of hospital stay for lesser or equal to 3 nights. Fatal grade adverse event happens when the procedure cause death.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study startJul 2023 (estimated)
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Why it stopped: The study is not relevant anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Northwell Health
- Responsible party
- Sponsor
- Investigators
- Mouen Khashab, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04052581
- Sponsor's protocol ID
- IRB00220604
- Status last verified
- Jul 2023
- First submitted
- 8 Aug 2019
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Outcomes in Patients Undergoing a Standard-of-care Combined POEM-TIF Procedure
- ClinicalTrials.gov ID
- NCT04052581
- Acronym / sponsor ID
- IRB00220604
- Conditions
- Achalasia, Gastroesophageal Reflux Disease
- Keywords
- Per oral Endoscopic Myotomy, Transoral Incisionless Fundoplication, POEM, TIF
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study is not relevant anymore.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Northwell Health
- Study start
- Jul 2023 (estimated)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 12 Aug 2019 (actual)
- 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.
Per Oral Endoscopic Myotomy has been established as a safe and effective treatment of Achalasia type I and II; however, it is limited by post-procedure gastroesophageal reflux. Transoral Incisionless Fundoplication (TIF) has been introduced as the endoscopic gold standard for anti-reflux procedure. Recently, combined POEM-TIF has been performed successfully as a standard of care treatment for patients with severe GER after POEM. We aim to study the safety and feasibility of performing POEM-TIF (POEM and TIF in the same endoscopic session). This study will also put the groundwork for a randomized clinical trial to further study the clinical outcome of the POEM-TIF procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POEM-TIF | – | Procedure: POEM-TIFAll participants will undergo the POEM-TIF in the same session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient age > 18 years old who have been diagnosis with either type I or type II Achalasia that has been proved by manometry
Key inclusion criteria (2 listed)
- Adult patient age greater than 18 years old
- Manometrically proven diagnosis of either type I or type II achalasia.
Key exclusion criteria (12 listed)
- Achalasia type III, or other esophageal dysmotility disorders.
- Completion of POEM with evidence of mucosal injury or compromise
- Previous surgery of the stomach such as sleeve gastrectomy, gastric bypass, Heller myotomy, partial or complete fundoplication, or partial/complete gastrectomy
- Esophageal lumen diameter greater than 4 cm
- Sigmoidization of the esophagus
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 |
|---|---|---|
| POEM-TIFTransoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session | Procedure or surgery | POEM-TIF |
Primary outcome
Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system
Time frame: 6 months
Safety will be evaluated by the frequency of severe adverse events with probable or definite attribution to the procedure based the ASGE lexicon scoring system. ASGE lexicon's severity grading system classify the adverse events into one of the four categories of mild, moderate, severe, and fatal. Mild adverse event means an adverse event that result in (1) Procedure aborted (or not started) because of an adverse event, (2) Post-procedure medical consultation, or (3) Unplanned hospital admission or prolongation of hospital stay for lesser or equal to 3 nights. Fatal grade adverse event happens when the procedure cause death.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Achalasia
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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.
Mouen Khashab principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
An observational study of Achalasia and Gastroesophageal Reflux Disease, run by Johns Hopkins University.
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 12 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: withdrawn, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Safety of POEM-TIF as assessed by the American Society of Gastrointestinal Endoscopy (ASGE) lexicon scoring system (time frame: 6 months). 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 28 Jul 2023.