Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia

Esophageal Achalasia Clinical Trial

— POETA  

Official title:

Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02518542
• Other study ID #: POETA
• Status: Recruiting
• Phase: N/A
• First received: December 8, 2014
• Last updated: August 7, 2015
• Start date: June 2014
• Est. completion date: June 2027

Study information

• Verified date: August 2015
• Source: Medical University of Vienna
• Contact: Department of Surgery, Medical University of Vienna
• Phone: +43 1 40400
• Email: sebastian.schoppmann[@]meduniwien.ac.at; erwin.rieder[@]meduniwien.ac.at
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss.

Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy.

Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM.

The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2027
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm

Exclusion Criteria:

• Contraindication for EGD

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Achalasia
• Esophageal Motility Disorders

Intervention

Procedure:
• Endoscopic intervention A
POEM: Per oral endoscopic myotomy
• Endoscopic intervention B
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
• Endoscopic intervention C
Endoscopic balloon dilatation
• Laparoscopic Surgery
Laparoscopic Heller myotomy

Locations

Country	Name	City	State
Austria	Department of Surgery, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Achalasia specific symptoms according to the Eckardt score (0-12)	Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3)	6 mo post-op	No
Secondary	Barium column height (cm) in esophagogram		6 mo post-op	No
Secondary	Resting pressure (mmHg) at the lower esophageal sphincter		6 mo post-op	No
Secondary	Stent migration	Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered.	p.o. day 1	No
Secondary	Percent of time (min)/24h that the pH is less than 4.0 in pH-metry		6 mo post-op