Esophageal Achalasia Clinical Trial
Official title:
Peroral Endoscopic Myotomy Versus Botulinum Toxin Injection in the Treatment of Medical Refractory Spastic Esophageal Disorders
To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in spastic esophageal disorders.
Spastic disorders of the esophagus encompass hyperactive conditions of the esophagus due to
either abnormal premature contractions or extreme vigor. In the current iteration of the
Chicago classification, spastic esophageal disorders include spastic (type III) achalasia,
diffuse esophageal spasm (DES), and hypercontractile (jackhammer) esophagus. Management of
these spastic esophageal disorders is challenging and not clearly defined. Several medical
therapies have been suggested and include acid suppression, nitrates, muscle relaxants, and
visceral analgesics. For those who fail to response to medical therapy, the treatment options
are limited.
Botulinum toxin (BTX) injection is an effective therapeutic option for spastic esophageal
disorders, however many patients experience symptoms relapse with this treatment requiring
repeated injections.
Heller myotomy is a surgical option for patients with esophageal spastic disorders. As
compared to other types of achalasia, the response rate to surgical myotomy was lower in
patient with spastic achalasia. The theoretical reason for this is that the disease involves
not only the lower esophageal sphincter (LES) but also the esophageal body. Given data to
suggest that surgical myotomy may be effective in treating patients with spastic esophageal
disorders, peroral endoscopic myotomy (POEM), which is a less invasive treatment modality,
has recently been studied for these difficult-to-treat patients. An initial study reported
high success rate of POEM for severe spastic esophageal disorders. The response rate as
defined by Eckardt score to ≤ 3 was 96% in spastic achalasia, 100% in DES and 70% in those
with Jackhammer esophagus after a median follow-up of 234 days in a largest case series of
medically refractory spastic esophageal disorders.
To date, the optimal treatment for patients with severe symptomatic esophageal spastic
disorders who fail medical therapy is unclear. Here, investigators aim to compare POEM and
BTX injection in a randomized design.
To compare the efficacy of peroral endoscopic myotomy and Botulinum toxin injection in
spastic esophageal disorders.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03962179 -
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
|
N/A | |
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 | |
Completed |
NCT04112693 -
Assessment of the Neuro-glio-epithelial Unit (NGEU) in Biopsies Taken During Peroral Endoscopic Myotomy (POEM) for Achalasia: a Feasibility and Safety Study.
|
N/A | |
Recruiting |
NCT05602272 -
Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach
|
||
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 | |
Not yet recruiting |
NCT06027190 -
Randomized Controlled Study of Optical 3D Navigated Repetitive Transcranial Magnetic Stimulation for Achalasia.
|
N/A |