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Under way, not recruiting

Endoscopic Versus Robotic Myotomy for Treatment of Achalasia

NCT06290882 · Germans Trias i Pujol Hospital · Updated 5 March 2024

What is being tested
Robotic Heller Myotomy; Peroral Endoscopic Myotomy
For
Achalasia Cardia
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 144 people. The full rules are on the registry page.
Where
Spain
When
Starts or started 1 Jan 2024, ends 1 Jan 2027. Registered 4 March 2024.
Results
None posted yet.

In the researchers' words

Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of the esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms of this pathology. Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world. In recent years, a large amount of data examining the effectiveness of POEM have appeared, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90%. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment…
ClinicalTrials.gov, NCT06290882

Sites

  • Elisenda Garsot SavallBadalona, Barcelona, Spain