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

Not Applicable

Recruiting

• Conditions: Esophageal Achalasia
• Interventions: Procedure: Endoscopic intervention C; Procedure: Endoscopic intervention A; Procedure: Laparoscopic Surgery; Procedure: Endoscopic intervention B

• Registration Number: NCT02518542
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-12-08
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-07
• Last Update Submitted: 2015-08-07
• Study First Posted: 2015-08-10
• Last Update Posted: 2015-08-10
• Primary Completion: 2024-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Read More

Exclusion Criteria

• Contraindication for EGD

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Per oral endoscopic therapy C	Endoscopic intervention C	Dilatation
Per oral endoscopic therapy A	Endoscopic intervention A	Per oral endoscopic myotomy
Laparoscopic surgery	Laparoscopic Surgery	Laparoscopic Heller myotomy
Per oral endoscopic therapy B	Endoscopic intervention B	Prolonged dilatation by implantation of large diameter stents.

Primary Outcome Measures

Name	Time	Method
Achalasia specific symptoms according to the Eckardt score (0-12)	6 mo post-op	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)

Secondary Outcome Measures

Name	Time	Method
Barium column height (cm) in esophagogram	6 mo post-op
Resting pressure (mmHg) at the lower esophageal sphincter	6 mo post-op
Stent migration	p.o. day 1	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.
Percent of time (min)/24h that the pH is less than 4.0 in pH-metry	6 mo post-op

Trial Locations

Locations (1)

Department of Surgery, Medical University of Vienna; 🇦🇹 Vienna, Austria