Study Results
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Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2014-06-06
2022-01-01
Brief Summary
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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)
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Short POEM
Patients in the Short POEM-group will undergo a Peroral Endoscopic Myotomy (POEM) extended for a total of 7 cm (including 4 cm above the esophago-gastric junction and 3cm on the stomach).
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
Long POEM
Patients in the Long POEM-group will receive a 12cm-long Peroral Endoscopic Myotomy (POEM), including 9 cm on the esophagus and 3cm on the gastric wall
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Age \> 18
3. Signed informed consent
4. Patient accepts to undergo scheduled follow-up after POEM
5. Eckardt score \> 3
6. ASA I-II-III
Exclusion Criteria
3. Current alcohol or drug addiction.
4. Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator make the subject a poor candidate for this study.
5. Severe congenital or acquired coagulopathy or INR \> 1.6
6. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
7. Hepatic cirrhosis w/ or w/o portal hypertension w/ or w/o esophageal varices
8. Eosinophilic esophagitis or Barrett Esophagus
9. Esophageal Strictures
18 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Guido Costamagna
Professor
Locations
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Fondazione Policlinico Universitario Agostino Gemelli
Roma, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Familiari P, Borrelli de Andreis F, Landi R, Mangiola F, Boskoski I, Tringali A, Perri V, Costamagna G. Long versus short peroral endoscopic myotomy for the treatment of achalasia: results of a non-inferiority randomised controlled trial. Gut. 2023 Aug;72(8):1442-1450. doi: 10.1136/gutjnl-2021-325579. Epub 2023 Apr 18.
Other Identifiers
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POEMLvS
Identifier Type: -
Identifier Source: org_study_id
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