NCT02518542

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
12mo left

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Jun 2014Jun 2027

Study Start

First participant enrolled

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2014

Completed
8 months until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Expected
Last Updated

August 10, 2015

Status Verified

August 1, 2015

Enrollment Period

10 years

First QC Date

December 8, 2014

Last Update Submit

August 7, 2015

Conditions

Esophageal Achalasia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (4)

  • 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

  • Percent of time (min)/24h that the pH is less than 4.0 in pH-metry

    6 mo post-op

Study Arms (4)

Per oral endoscopic therapy A

ACTIVE COMPARATOR

Per oral endoscopic myotomy

Procedure: Endoscopic intervention A

Per oral endoscopic therapy B

ACTIVE COMPARATOR

Prolonged dilatation by implantation of large diameter stents.

Procedure: Endoscopic intervention B

Per oral endoscopic therapy C

ACTIVE COMPARATOR

Dilatation

Procedure: Endoscopic intervention C

Laparoscopic surgery

ACTIVE COMPARATOR

Laparoscopic Heller myotomy

Procedure: Laparoscopic Surgery

Interventions

Endoscopic intervention APROCEDURE

POEM: Per oral endoscopic myotomy

Per oral endoscopic therapy A
Endoscopic intervention BPROCEDURE

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 B
Endoscopic intervention CPROCEDURE

Endoscopic balloon dilatation

Per oral endoscopic therapy C
Laparoscopic SurgeryPROCEDURE

Laparoscopic Heller myotomy

Laparoscopic surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Contraindication for EGD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery, Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Esophageal Achalasia

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Department of Surgery, Medical University of Vienna

CONTACT

+43 1 40400sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv. Doz. Dr. Erwin Rieder

Study Record Dates

First Submitted

December 8, 2014

First Posted

August 10, 2015

Study Start

June 1, 2014

Primary Completion

June 1, 2024

Study Completion (Estimated)

June 1, 2027

Last Updated

August 10, 2015

Record last verified: 2015-08

Locations

AU(1)