POEM: Long vs Short Myotomy for Achalasia. RCT

NCT03450928 | Unknown

• 1 other identifier: POEMLvS
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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)

Conditions

Achalasia

Keywords

Peroral Endoscopic Myotomy; Endoscopy; POEM; Submucosal endoscopy

Outcome Measures

Primary Outcomes (1)

• Non-inferiority of a Short-POEM compared to a Long-POEM

  Treatment success, defined as an Eckard score ≤ 3. The Eckardt score is a clinical score for evaluating the severity of achalasia-related symptoms. Eckardt score varies between 0 and 12. Questions are asked about the frequency of dysphagia, regurgitation and retrosternal pressure sensation. Depending on whether any of these symptom occurrs, never, occasionally, daily or with each meal, a symptom score between 0 and 3 is applied. In addition a symptom score of 0-3 is assigned to the degree of weight loss (0 - No weight loss; 1 - weight loss \< 5Kg, 2 - weight loss between 5 and 10Kg, 3- weight loss \> 10Kg). Each symptom score (dysphagia, regurgitation, retrosternal pressure, and wieight loss) is summed to the other. Thus, a completely asymptomatic patient has a score of 0 and the most severely affected patient had a maximum score of 12.

  2 years

Secondary Outcomes (7)

• Basal Lower Esophageal Sphincter (LES) pressure

  Before POEM, 6 months and 2 years after the procedure

• 4-second Integrated Relaxation Pressure (4sIRP)

  Before POEM, 6 months and 2 years after the procedure

• Side effects and complications

  Baseline to 2 years

• Gastro-Esophageal Reflux (GER) symptom assessment

  baseline, 6 months and 2 years after POEM

• Esophageal pH-monitoring study

  6 months after POEM

Study Arms (2)

Short POEM

ACTIVE COMPARATOR

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).

Procedure: Peroral Endoscopic Myotomy (POEM)

Long POEM

ACTIVE COMPARATOR

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

Procedure: Peroral Endoscopic Myotomy (POEM)

Interventions

Peroral Endoscopic Myotomy (POEM) PROCEDURE

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; Short POEM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of achalasia (type I and II)
• Age \> 18
• Signed informed consent
• Patient accepts to undergo scheduled follow-up after POEM
• Eckardt score \> 3
• ASA I-II-III

You may not qualify if:

• Pregnancy or nursing
• Current alcohol or drug addiction.
• 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.
• Severe congenital or acquired coagulopathy or INR \> 1.6
• Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
• Hepatic cirrhosis w/ or w/o portal hypertension w/ or w/o esophageal varices
• Eosinophilic esophagitis or Barrett Esophagus
• Esophageal Strictures

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli

Roma, RM, 00168, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 37072180 DERIVED

MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Pietro Familiari, MD

CONTACT

00390630156580; pietrofamiliari@tiscali.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: March 1, 2018
• Study Start: June 6, 2014
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2022
• Last Updated: March 1, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)