POEM: Long vs Short Myotomy for Achalasia. RCT

Catholic University of the Sacred Heart

Status: Unknown

Conditions: Achalasia

Treatments: Procedure: Peroral Endoscopic Myotomy (POEM)

Study type: Interventional

Funder types: Other

Identifiers

NCT03450928

POEMLvS

Details and patient eligibility

About

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)

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of achalasia (type I and II)
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

1. Prior surgical treatment of achalasia (previous endoscopic balloon dilation or botox injection ARE NOT exclusion criteria)
2. Pregnancy or nursing
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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Short POEM

Active Comparator group

Description:

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).

Treatment:

Procedure: Peroral Endoscopic Myotomy (POEM)

Long POEM

Active Comparator group

Description:

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

Treatment:

Procedure: Peroral Endoscopic Myotomy (POEM)