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Through-the-Mouth surgery vs keyhole surgery: which works better for a rare swallowing disorder?

NCT ID NCT07814027

Symptom relief Sponsor: Minia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Achalasia makes it hard to swallow because the valve between the esophagus and stomach stays tight. Researchers randomly assign 220 adults with newly diagnosed achalasia to two procedures that cut that valve muscle: POEM, done through the mouth with no skin cuts, or laparoscopic Heller myotomy with a reflux wrap, done through small abdominal incisions. The trial asks whether POEM controls symptoms about as well as the laparoscopic approach after 12 months, while tracking reflux and complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Peroral endoscopic myotomy (POEM), a procedure that cuts the tight valve muscle from inside the esophagus
What this could lead to
If POEM works about as well as laparoscopic Heller myotomy, people with achalasia could choose a treatment with no abdominal incisions and a shorter recovery.
What could go wrong
POEM does not include a reflux wrap, so heartburn may be more common afterward. The trial may show POEM is not quite as good at controlling swallowing symptoms, and results from one hospital may not apply everywhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 18 to 75 years. * New diagnosis of primary achalasia confirmed by high-resolution manometry according to the Chicago Classification version 4.0 (elevated median integrated relaxation pressure with 100% failed peristalsis), of any subtype (I, II or III). * Eckardt symptom score of 4 or more at baseline. * Upper endoscopy excluding mechanical obstruction, malignancy and pseudoachalasia. * Treatment-naive with respect to definitive therapy (no prior Heller myotomy, prior POEM or prior pneumatic dilation). Prior botulinum-toxin injection is permitted if administered at least 6 months before enrollment. * Fit for general anesthesia (American Society of Anesthesiologists physical status I to III). * Able to provide written informed consent and to comply with the follow-up schedule. Exclusion Criteria: * Prior esophageal or gastric surgery, prior myotomy (surgical or endoscopic), or prior pneumatic dilation. * Secondary (pseudo-) achalasia, suspected or confirmed esophagogastric malignancy, or eosinophilic esophagitis. * Sigmoid or end-stage megaesophagus (tortuous, dilated greater than 7 cm) considered unsuitable for myotomy. * Severe esophageal varices, significant coagulopathy, or therapy with anticoagulants that cannot be safely interrupted. * Significant cardiopulmonary disease precluding general anesthesia or capnoperitoneum / capnomediastinum. * Pregnancy or breastfeeding. * Body mass index below 18.5 kg/m2 with severe malnutrition requiring prior nutritional optimization (may be re-screened after optimization). * Inability to provide informed consent or anticipated non-compliance with follow-up.

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Conditions

The condition(s) this trial relates to.

achalasia dyskinesia of esophagus Esophageal Achalasia gastroesophageal reflux disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal achalasia Esophageal motility disorders Gastroesophageal reflux

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University

    Minya, Minya Governorate, 61519, Egypt

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