DysphagiaVADYSMANCT06872255
Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia
A study testing Per Oral Endoscopic Myotomy (POEM) in people with Dysphagia and Dysphagia, Esophageal, run by Institute for Clinical and Experimental Medicine at 2 sites in 2 countries.
Trial summary
Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dysphagia, Dysphagia, Esophageal, Healthy
- What is being tested?
- Per Oral Endoscopic Myotomy (POEM)
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Apr 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.
- Refractory (> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.
- X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial/total stagnation of the contrast solution above the GEJ
- Endoluminal planimetry: EGJ-DI < 3 mm2/mmHg (with 40ml)
- Age above 18 years
- Signed informed consent form
Who cannot join
- No previous attempt with at least one prokinetic drug
- Previous esophageal myotomy (open, laparoscopic or endoscopic)
- Primary esophageal motility disorder (achalasia etc.)
- Active erosive esophagitis
- Active peptic ulcer disease
- Esophageal stricture (peptic, malignant, other)
Show all 15Show fewer
- Partial or complete supradiaphragmatic migration of the wrap and/or stomach (Hinder Type III - IV), Large hiatal hernia more than 5 cm
- Known eosinophilic esophagitis
- Severe coagulopathy
- Esophageal or gastric varices
- Advanced liver cirrhosis (Child B or Child C)
- Pregnancy or puerperium
- Malignant or pre-malignant esophageal diseases (dysplasia): patients with a history of such disease after its cure are eligible for enrolment
- Any other condition, which in the opinion of the investigator would interfere with study requirements
- Known gastroparesis
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Czechia1 site
St. Anne's University Hospital Brno, Czech Republic
Brno, 60200
Martin Vašátko, MD, +420 739 476 451, martin.vasatko@fnusa.cz
Jan Martínek, prof., MD, +420 723 708 839, jan.martinek@fnusa.cz
Slovakia1 site
University Hospital Trnava
Trnava, 91701
Rastislav Husťak, MD, +421 33/593 81 11, rhustak@gmail.com
Ján Ušák, MD, +421 33/593 81 11, jan.usak@gmail.com
About this study
Official title: A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)
Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.
- Conditions
- Dysphagia, Dysphagia, Esophageal, Healthy
- Being tested
- Per Oral Endoscopic Myotomy (POEM)
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Per Oral Endoscopic Myotomy (POEM)Procedure or surgery
All procedures will be performed by an experienced endoscopist, with a sufficient experience in "third space" endoscopy (at least 100 POEMs) under general anesthesia (internal preoperative examination is necessary) with a high-definition endoscope, fitted with a plastic distal attachment. Before the procedure, the patients will be administered intravenous antibiotics. Exclusively CO2 will be used for insufflation. POEM will be performed in a similar way as in patients with achalasia - the procedure consists of 4 steps: (1) mucosal incision and tunnel entry, (2) submucosal tunneling, (3) myotomy, and (4) closure of the mucosal entry with endoscopic clips or other closure devices. Perioperative protocol might differ according the usual way of performing POEM in a given center.
| Study group | Role | What they receive |
|---|---|---|
| POEM arm | Experimental | Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia Receives: Procedure: Per Oral Endoscopic Myotomy (POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and safety of POEM in patients with postfundoplication dysfagia
The primary outcome will be proportion of patients with treatment success defined as Eckardt score ≤ 2 and its decrease by at least 1 point after POEM at 6 months
Measured: 6 months
Secondary outcomes (11)
Eckardt score
The Eckardt score is the grading system used for the evaluation of severity of symptoms in patients with esophageal achalasia. Four symptoms are assessed (dysphagia, regurgitation, chest pain and weight loss) and their severity ranges from 0 (no symptom) to 3 (with every meal). Total score is their sum and ranges from 0 to 12
Measured: At baseline and after 3, 6 and 12 months
Mellow - Pinkas score
The Mellow - Pinkas score is used to assess dysphagia grade before and after the interventions. Total score ranges from 0 to 3 (0 = able to eat normal diet, 1 = able to swallow some solid foods, 2 = able to swallow only semi solid foods, 3 = able to swallow liquids only)
Measured: At baseline and after 3, 6 and 12 months
PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)
The PAGI-QoL questionnaire contains of 30 items with five subscales: (1) daily activities; (2) clothing; (3) diet/food habits; (4) relationship; and (5) psychological well-being and distress. Each item is scored on a 6-point Likert scale, with response options ranging from 0 (none) to 5 (severe problem all of the time). Subscale scores are calculated by averaging the item responses. A total score is calculated by averaging subscale scores. Higher score means impairment in quality of life.
Measured: At baseline and after 3, 6 and 12 months
GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)
The GERD-HRQL questionnaire was developed and validated to measure changes of typical GERD symptoms such as heartburn and regurgitation in response to surgical or medical treatment. Higher (greater) possible score means worst symptoms - ranging from 0 to 75.
Measured: At baseline and after 3, 6 and 12 months
Integrated Relaxation Pressure (IRP)
High resolution manometry - Median IRP recorded from 10 supine swallows, measured in mmHg. A value >15 mmHg indicates EGJ outflow obstruction.
Measured: At baseline and after 6 months
Endoluminal planimetry (Endoflip)
Pyloric distensibility measured by impedance planimetry (EndoFLIP device)
Measured: At baseline and after 6 months
Esophagogram
Esophagogram provides valuable information of the fundoplication, better appreciate a paraesophageal hernia and information on esophageal emptying.
Patients will be advised overnight fasting prior to timed barium esophagogram. A contrast agent (e.g. barium, usually 100 to 250 mL) is ingested orally within 15-20 seconds. Left posterior oblique X-ray will be taken 2 and 5 minutes after contrast agent ingestion. Maximum esophageal width and column hights will be recorded at 2 and 5 minutes.
Measured: At baseline and after 6 months
Eckardt score
The Eckardt score is used to assess the severity of achalasia symptoms. It is based on the four main symptoms of achalasia: dysphagia, regurgitation, chest pain and weight loss. Each symptom has four levels of severity: none = 0 point, occasional = 1 point, daily = 2 points, each meal = 3 points. The sum of the points gives the final score. Final score scale: 0 (best) - 12 (worst). Treatment success is defined as a decrease of Eckardt score by at least 1 point and an overall Eckardt score ≤ 2.
Measured: At and after 3 and 12 months
GERD
Presence of reflux esophagitis based on endoscopy findings.
Measured: At baseline and after 3, 6 and 12 months
Esophageal 24h-Hour pH metry
An esophageal pH test measures how often stomach acid enters to the esophagus. It also measures how long the acid stays there. The test involves placing a catheter into the esophagus. The catheter or device will measure an acid level (known as pH level) for 24 hours. Post-POEM Esophageal acid exposure (DeMeester score, proportion of time with pH below 4)After
Measured: At 3 months after procedure
PPI/H2 antagonists
PPI's and/or H2 antagonists use before and after procedure (POEM).
Measured: At baseline and after 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start1 Apr 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysphagiaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients with refractory (\> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline, with proven obstruction of gastroesofageal junction (EGJOO)
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Clinical and Experimental Medicine
- Sponsor type
- Other government
- Collaborators
- University Hospital Trnava, St. Anne's University Hospital Brno, Czech Republic
- Responsible party
- Principal investigator, Prof. Jan Martinek, MD, PhD, AGAF, St. Anne's University Hospital Brno, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872255
- Sponsor's protocol ID
- VADYSMA
- Acronym
- VADYSMA
- Status last verified
- Feb 2025
- First submitted
- 10 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Pilot Trial of Per-oral Endoscopic Myotomy (POEM) in Patients with Postfundplication Dysphagia (VADYSMA Trial)
- ClinicalTrials.gov ID
- NCT06872255
- Acronym / sponsor ID
- VADYSMA / VADYSMA
- Conditions
- Dysphagia, Dysphagia, Esophageal, Healthy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute for Clinical and Experimental MedicineOther government
- Collaborators
- University Hospital Trnava, St. Anne's University Hospital Brno, Czech Republic
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 12 Mar 2025 (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.
Laparoscopic fundoplication represents the standard antireflux procedure, when conservative measures fail. However, any type of fundoplication may be accompanied by adverse events. Postfundoplication dysphagia (PFD) may hamper results of anti-reflux surgery. Endoscopic pneumatic dilation has been considered as the first line treatment option for persistent PFD. However, studies have not confirmed its effectiveness in this indication. Peroral endoscopic myotomy (POEM) became a standard treatment for the management of esophageal achalasia and moreover has also been assessed in a small cohort of patients with refractory PFD and some patients achieved significant treatment success. We plan to perform a prospective international cohort multicenter study assessing the efficacy of POEM in patients with persistent and severe PFD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients with refractory (> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline, with proven obstruction of gastroesofageal junction (EGJOO)
| Arm | Type | Receives |
|---|---|---|
| POEM arm | Experimental | Procedure: Per Oral Endoscopic Myotomy (POEM)Patients, who will undergo peroral endoscopic myotomy for postfundoplication dysphagia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients after laparoscopic fundoplication procedure by Nissen (total, 360°), Dor (anterior, 180°) or Toupet (posterior, 270°) for gastroesophageal reflux disease no later than 10 years before enrolment.
- Refractory (> 6 months) and severe dysphagia after fundoplication procedure defined as an Eckardt score ≥3 and Mellow - Pinkas score ≥2 at baseline.
- X-ray (contrasted radiographic examination of the esophagus) characterized by both: a.) tapered narrowing of the distal esophagus and GEJ; b.) partial/total stagnation of the contrast solution above the GEJ
- Endoluminal planimetry: EGJ-DI < 3 mm2/mmHg (with 40ml)
- Age above 18 years
Key exclusion criteria (15 listed)
- No previous attempt with at least one prokinetic drug
- Previous esophageal myotomy (open, laparoscopic or endoscopic)
- Primary esophageal motility disorder (achalasia etc.)
- Active erosive esophagitis
- Active peptic ulcer disease
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 |
|---|---|---|
| Per Oral Endoscopic Myotomy (POEM)All procedures will be performed by an experienced endoscopist, with a sufficient experience in "third space" endoscopy (at least 100 POEMs) under general anesthesia (internal preoperative examination is necessary) with a high-definition endoscope, fitted with a plastic distal attachment. Before the procedure, the patients will be administered intravenous antibiotics. Exclusively CO2 will be used for insufflation. POEM will be performed in a similar way as in patients with achalasia - the procedure consists of 4 steps: (1) mucosal incision and tunnel entry, (2) submucosal tunneling, (3) myotomy, and (4) closure of the mucosal entry with endoscopic clips or other closure devices. Perioperative protocol might differ according the usual way of performing POEM in a given center. | Procedure or surgery | POEM arm |
Primary outcome
Efficacy and safety of POEM in patients with postfundoplication dysfagia
Time frame: 6 months
The primary outcome will be proportion of patients with treatment success defined as Eckardt score ≤ 2 and its decrease by at least 1 point after POEM at 6 months
11 secondary outcomes
Eckardt score
Time frame: At baseline and after 3, 6 and 12 months
Mellow - Pinkas score
Time frame: At baseline and after 3, 6 and 12 months
PAGI-QOL score (Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life)
Time frame: At baseline and after 3, 6 and 12 months
GERD-RHQL score (Gastroesophageal Reflux Disease Health-related Quality of Life)
Time frame: At baseline and after 3, 6 and 12 months
Integrated Relaxation Pressure (IRP)
Time frame: At baseline and after 6 months
Endoluminal planimetry (Endoflip)
Time frame: At baseline and after 6 months
Esophagogram
Time frame: At baseline and after 6 months
Eckardt score
Time frame: At and after 3 and 12 months
GERD
Time frame: At baseline and after 3, 6 and 12 months
Esophageal 24h-Hour pH metry
Time frame: At 3 months after procedure
PPI/H2 antagonists
Time frame: At baseline and after 3, 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Per Oral Endoscopic Myotomy (POEM) in people with Dysphagia and Dysphagia, Esophageal, run by Institute for Clinical and Experimental Medicine at 2 sites in 2 countries.
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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia, Slovakia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jan Martínek, prof., MD (+420 723 708 839, jan.martinek@fnusa.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy and safety of POEM in patients with postfundoplication dysfagia (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 12 Mar 2025.