Trial comparing treatments for Esophageal Achalasia
Official title POEM Versus Laparoscopic Heller Myotomy With Dor Fundoplication for Esophageal Achalasia
ClinicalTrials.gov ID: NCT07814027
What this study is testing
- What it's testing
- Achalasia is a disorder of the esophagus in which the muscular valve between the esophagus and the stomach fails to relax, and the body of the esophagus loses its normal coordinated squeezing movement. People with achalasia have difficulty swallowing both solids and liquids, bring up undigested food, may have chest pain, and often lose weight.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Minya, Minya Governorate, Egypt
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here - ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Minya, Minya Governorate, Egypt. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.