Through-the-Mouth surgery vs keyhole surgery: which works better for a rare swallowing disorder?
NCT ID NCT07814027
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
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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
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About 220 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Minia University Hospitals - Department of Surgery, Faculty of Medicine, Minia University
Minya, Minya Governorate, 61519, Egypt
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- Unnecessary test? study questions routine throat tube before reflux surgery