Clinical trial NCT03450928: POEM: Long vs Short Myotomy for Achalasia. RCT
Official title: Peroral Endoscopic Myotomy (POEM) for the Treatment of Esophageal Achalasia: Long vs Short Myotomy. Prospective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Achalasia
Keywords: Peroral Endoscopic Myotomy
Endoscopy
POEM
Submucosal endoscopy
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility criteria: 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

Primary outcomes:
measure: Non-inferiority of a Short-POEM compared to a Long-POEM
timeFrame: 2 years
Secondary outcomes:
measure: Basal Lower Esophageal Sphincter (LES) pressure
timeFrame: Before POEM, 6 months and 2 years after the procedure
measure: 4-second Integrated Relaxation Pressure (4sIRP)
timeFrame: Before POEM, 6 months and 2 years after the procedure
measure: Side effects and complications
timeFrame: Baseline to 2 years
measure: Gastro-Esophageal Reflux (GER) symptom assessment
timeFrame: baseline, 6 months and 2 years after POEM
measure: Esophageal pH-monitoring study
timeFrame: 6 months after POEM
measure: Operating time
timeFrame: During the endoscopic procedure
measure: Quality of life
timeFrame: baseline, 6 months and 2 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
state: RM
Study officials:
References: