Clinical Impact of Peroral Endoscopic Myotomy for Esophageal Achalasia

Status Recruiting

Clinical Trial Summary

Achalasia is a rare esophageal motility disorder, which is characterized clinically by symptoms of dysphagia, regurgitation, weight loss and chest pain. These symptoms are primarily caused by incomplete relaxation of a frequently hypertensive lower esophageal sphincter (LES) and to some extent by a lack of peristalsis in the tubular esophagus. Unfortunately, no therapy returns normal esophageal function. Treatment is therefore directed at lowering the LES pressure, with the aim of reducing the functional obstruction to bolus transit at this site. Current treatments can be endoscopic or surgical. Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers. The investigators purpose was to further evaluate the efficacy and the feasibility of POEM for patients with achalasia in a prospective larger study.

Clinical Trial Description

1. Patients were eligible for enrollment in the study if they had an Eckardt symptom score ≥ 4. The diagnosis of achalasia was made on the basis of the absence of peristalsis and on impaired relaxation of the LES on established methods (barium swallow, manometry, esophagogastroduodenoscopy (EGD)). Exclusion criteria were severe cardiopulmonary disease or other serious disease leading to unacceptable surgical risk, pseudoachalasia, and megaesophagus (diameter of > 7 cm).

2. All patients were scheduled for a follow-up visit at 1 month after POEM for EGD and manometry. Symptoms were assessed 1 month after treatment in the clinic and every 3 months thereafter via telephone questionnaires.

3. The primary outcome of the study was therapeutic success (a reduction in the Eckardt score to ≤3) at the follow-up assessment. The secondary outcomes included procedure-related adverse events, LES pressure on manometry pre- and post POEM, reflux symptoms and medication use before and after POEM, and procedure-related parameters such as procedure time, hospital stay, and myotomy length. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Esophageal Achalasia

Clinical Trial Details

NCT number	NCT01649843
Study type	Interventional
Source	Shanghai Zhongshan Hospital
Contact	Ping-Hong Zhou, MD,PhD
Email	zhou1968@yahoo.cn
Status	Recruiting
Phase	N/A
Start date	August 2010
Completion date	December 2014

View Details

See also
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Active, not recruiting	`NCT00188344` - A Randomized Comparison of Laparoscopic Myotomy and Pneumatic Dilatation for Achalasia	N/A
Recruiting	`NCT04578769` - Assessment of Different Modified POEM for Achalasia	N/A
Not yet recruiting	`NCT05010889` - Quality of Life After POEM for Achalasia
Recruiting	`NCT02572193` - To Assess the Feasibility of Same Day Discharge Following a POEM Procedure	N/A
Terminated	`NCT02606578` - Achalasia Patient Reported Outcomes
Active, not recruiting	`NCT01750385` - Bacteremia and Procalcitonin Levels in Peroral Endoscopic Myotomy for Achalasia	N/A
Active, not recruiting	`NCT03404739` - Single- Versus Multiple-dose Antimicrobial Prophylaxis for The Prevention of Infectious Complications Associated With Peroral Endoscopic Myotomy(POEM) for Achalasia	Phase 2/Phase 3
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Recruiting	`NCT05113173` - Study on the Relationship Between Pathological Features of Achalasia and Prognosis of Per-oral Endoscopic Myotomy
Completed	`NCT02999451` - Snare-assisted POEM for Treatment of Esophageal Achalasia	N/A
Completed	`NCT00490750` - Laparoscopic Dor Versus Toupet Fundoplication for the Treatment of Idiopathic Esophageal Achalasia	N/A
Recruiting	`NCT02518542` - Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia	N/A
Recruiting	`NCT00260585` - Esophageal Cancer Risk Registry
Recruiting	`NCT05899842` - Routine Versus Symptomatic Protein Pump Inhibitor Therapy for Prevention of Gastroesophageal Reflux After Per Oral Endoscopic Myotomy for Esophageal Achalasia	N/A
Completed	`NCT03702647` - Ropivacaine For Post-POEM Pain Control	N/A
Recruiting	`NCT01637311` - Peroral Endoscopic Remyotomy for Failed Heller Myotomy	N/A
Completed	`NCT00004416` - Randomized Study of Botulinum Toxin Type A for Achalasia	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.