NCT03450928

POEM: Long vs Short Myotomy for Achalasia. RCT

Peroral Endoscopic Myotomy (POEM) for the Treatment of Esophageal Achalasia: Long vs Short Myotomy. Prospective Randomized Controlled Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Per-Oral Endoscopic Myotomy (POEM) is increasingly used for the treatment of achalasia. In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter (8cm). The clinical efficacy of both procedure is comparable. This study intends to investigate if clinical outcomes of POEM depends on the length of esophageal myotomy, in patients with classic-type achalasia (type I and type II according to Chicago Classification)

Detailed description

Peroral Endoscopic Myotomy myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery). The technique includes the incision of the mucosa in the esophageal body, the submucosal dissection of the distal esophagus and the creation of a submucosal tunnel in the distal esophagus and proximal gastric body, and the esophageal myotomy. The procedure is performed transorally, using a flexible endoscope. In published series, a 12cm-POEM is usually performed. Surgical myotomy is typically shorter, being protracted for about 8cm. The clinical efficacy of POEM and surgical myotomy is more likely to be similar according to the most recent published series. In this randomized controlled trial (non-inferiority trial) we evaluate the outcomes of POEM according to the length of the esophageal myotomy. Patients with type I and II achalasia will be randomly assigned to one of the two groups, long--myotomy (LM) and short--myotomy (SM). Patients in the LM-group will receive a 12cm-long POEM (including 3cm on the stomach); in the SM-group patients will undergo a POEM extended for 7 cm (including 3cm on the stomach). During follow-up, High Resolution Manometry (HRM), Esophageal pH-monitoring study and Esophagogastroduodenoscopy (EGD) will be regularly performed and symptoms assessed with the use of the Eckardt score (ECKs). The main hypothesis is that the results of a SM are not inferior to the results of a LM. Calculated sample size is 200 patients

Conditions

• Achalasia

Interventions

Type	Name	Description
PROCEDURE	Peroral Endoscopic Myotomy (POEM)	Peroral endoscopic myotomy (POEM) is a minimally invasive intervention for the treatment of esophageal achalasia. POEM includes different steps: 1. Lifting of the esophageal mucosa, with the injection of saline solution, and mucosal incision on the esophageal body (approximately 12 or 7 cm above the esophagogastric junction, for about 1-2cm) 2. Advance of the endoscope into the submucosa, repeated submucosal injection and dissection of a submucosal tunnel into the distal esophagus up to 3 cm into the gastric wall. 3. Myotomy of the distal esophagus, cardia and gastric wall, starting 3 cm below the mucosal incision 4. After the completion of myotomy, and check for mucosal integrity, the mucosal incision is closed using endoscopic clips

Timeline

• Start date: 2014-06-06
• Primary completion: 2020-01-01
• Completion: 2022-01-01
• First posted: 2018-03-01
• Last updated: 2018-03-01

Locations

1 site across 1 country: Italy