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

NCT ID: NCT02518542

Last Updated: 2015-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Esophageal Achalasia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Per oral endoscopic therapy A

Per oral endoscopic myotomy

Group Type ACTIVE_COMPARATOR

Endoscopic intervention A

Intervention Type PROCEDURE

POEM: Per oral endoscopic myotomy

Per oral endoscopic therapy B

Prolonged dilatation by implantation of large diameter stents.

Group Type ACTIVE_COMPARATOR

Endoscopic intervention B

Intervention Type PROCEDURE

PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.

Per oral endoscopic therapy C

Dilatation

Group Type ACTIVE_COMPARATOR

Endoscopic intervention C

Intervention Type PROCEDURE

Endoscopic balloon dilatation

Laparoscopic surgery

Laparoscopic Heller myotomy

Group Type ACTIVE_COMPARATOR

Laparoscopic Surgery

Intervention Type PROCEDURE

Laparoscopic Heller myotomy

Interventions

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Endoscopic intervention A

POEM: Per oral endoscopic myotomy

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Endoscopic intervention C

Endoscopic balloon dilatation

Intervention Type PROCEDURE

Laparoscopic Surgery

Laparoscopic Heller myotomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Contraindication for EGD
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Erwin Rieder

Priv. Doz. Dr. Erwin Rieder

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Surgery, Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Department of Surgery, Medical University of Vienna

Role: CONTACT

Facility Contacts

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Sebastian F Schoppmann, MD

Role: primary

+43 1 40400 ext. 5621

Erwin Rieder, MD

Role: backup

+43 1 40400 ext. 5621

Other Identifiers

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POETA

Identifier Type: -

Identifier Source: org_study_id

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