Myotomy for Achalasia
(PREMEDIA Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether a shorter procedure, Per-Oral Endoscopic Myotomy (POEM), can be as effective as the standard longer procedure for individuals with achalasia, a condition where the esophagus struggles to move food down. Researchers aim to determine if a smaller cut in the muscle at the bottom of the esophagus can relieve symptoms and reduce side effects compared to the standard larger cut (standard myotomy). Participants will have their medical records reviewed and will complete a few questionnaires over two years. This trial may suit those diagnosed with certain types of achalasia who frequently experience trouble swallowing but have not undergone similar treatments. As a Phase 3 trial, this research represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you use opioid medications weekly or more often, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the standard Per-Oral Endoscopic Myotomy (POEM) is generally safe and well-tolerated. In past studies, doctors successfully completed POEM in 97.8% of patients, with 93.8% experiencing symptom relief. Side effects were rare, indicating it is usually a safe option.
For the tailored short myotomy, early results suggest it is also safe. A study with 46 patients who underwent the shorter procedure showed excellent short-term results. Patients experienced similar symptom relief, and the shorter procedure might even reduce the risk of side effects.
Both the standard and short myotomy have good safety records, suggesting these procedures are generally well-tolerated by patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments for achalasia because they offer potentially more personalized approaches to managing the condition. Unlike traditional long myotomy, the tailored short myotomy is designed to be less invasive, focusing only on the specific areas of muscle that are problematic. This targeted approach may result in quicker recovery times and fewer complications. Both standard and tailored myotomy aim to relieve the symptoms of achalasia, but the tailored approach could provide a more customized and effective treatment option for patients by limiting unnecessary muscle disruption.
What evidence suggests that this trial's treatments could be effective for achalasia?
This trial will compare the effectiveness of two treatments for achalasia: the Standard Myotomy and the Tailored Short Myotomy. Research has shown that both the standard and customized short myotomy effectively treat achalasia, a condition that makes swallowing difficult. Studies have found that the standard procedure, known as per-oral endoscopic myotomy (POEM), is well-established and maintains high success rates over time. Other studies suggest that the customized short myotomy can be equally effective, with similar success rates. The shorter procedure might also result in fewer side effects, making it a potentially safer option. Both treatments show promise in relieving the symptoms of achalasia.678910
Are You a Good Fit for This Trial?
This trial is for individuals with achalasia, a condition that makes swallowing difficult. Participants must allow access to their medical records and be willing to complete questionnaires up to six times over two years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either a short tailored (4cm) or standard (9cm) Per-Oral Endoscopic Myotomy (POEM) procedure
Follow-up
Participants are monitored for symptom improvement and side effects, including acid reflux and esophageal emptying, with follow-up testing and questionnaires
Optional Tissue Sample Collection
Participants may provide a sample of muscle tissue for research purposes
What Are the Treatments Tested in This Trial?
Interventions
- Standard Myotomy
- Tailored Short Myotomy
Trial Overview
Researchers are testing whether a shorter cut in the esophagus muscle (Tailored Short Myotomy) is as effective and has fewer side effects than the standard longer cut (Standard Myotomy) in treating swallowing difficulties.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
Outcomes of 100 Patients Greater than 4 Years after POEM for ...
Per-oral endoscopic myotomy (POEM) is a well-established endoscopic therapy for achalasia with excellent short-term efficacy, but long-term outcomes data are ...
Long‐term outcomes of treatment for achalasia ...
The efficacy of LHM ranged from 49.8% to 98.1% after a median of over 5 y of follow-up. Data on the efficacy of LHM vary between reports; these ...
Comparative efficacy of short versus standard esophageal ...
1. suggests that a shorter esophageal myotomy is as effective and safe as the standard procedure for treating S-shaped achalasia, potentially leading to fewer ...
Durability and reflux outcomes of peroral endoscopic myotomy ...
Historically, laparoscopic Heller myotomy (LHM) with partial fundoplication has served as the gold standard surgical treatment for achalasia.
Short esophageal myotomy versus standard ...
POEM with short myotomy is effective and safe for the short-term treatment of sigmoid and advanced sigmoid achalasia, with a high (93%) clinical success rate ...
Safety and efficacy of peroral endoscopic myotomy with ...
POEM was successfully accomplished in most patients (97.8%). The primary outcome of treatment success occurred in 45 of 48 patients (93.8%) in ...
Evaluating limitations and long-term outcomes in short ...
3. Bi Y-W, Ru N, Li L-S, et al. Per-oral endoscopic myotomy is safe and effective for pediatric patients with achalasia: a long-term follow-up study. World J ...
Efficacy and Safety of Peroral Endoscopic Myotomy in ...
Overall, the pooled technical success, clinical success and adverse events rate of rescue POEM were 98.0% (95% confidence interval [CI], 96.6% ...
Efficacy and Safety of Peroral Endoscopic Myotomy for ...
Overall, the pooled clinical success was achieved in 211 sigmoid-type achalasia patients [90.4%; 95% confidence interval (CI), 85.5%−93.8%]. The ...
Efficacy and safety of full-thickness versus circular peroral ...
The primary outcome was clinical success, while secondary outcomes included change in achalasia severity scores, post-POEM gastroesophageal ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.