European Achalasia Trial.

A prospective randomized multi-center study comparing endoscopic pneumodilation and laparoscopic myotomy as treatment of idiopathic achalasia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26612

Enrollment

200

Registered

2005-06-02

Start date

2003-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The major aim of this prospective, randomized, multi-center study is to compare the two treatments, namely pneumatic dilation and laparoscopic Heller myotomy.

Eligibility

Inclusion criteria

Inclusion criteria: Between 18-75 yr of age, manometric diagnosis of achalasia, Eckardt score >3, signed informed consent.

Exclusion criteria

Exclusion criteria: Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk, previous treatment except treatment with nitroderivatives, Ca++ channel blockers or sildenafil or dilation with Savary bougies or balloons of 2 cm diameter or smaller, pseudo-achalasia, mega-esophagus (> 7cm), previous esophageal or gastric surgery (except for gastric perforation), not capable to fill out questionnaires (f.e. due to language barrier), not available for follow-up, esophageal diverticula in the distal esophagus.

Design outcomes

Primary

Measure	Time frame
1. Symptom control; 2. Therapeutic succes.	—

Contacts

Public ContactG.E.E. Boeckxstaens

Academic Medical Center (AMC), Department of Gastroenterology, C2-328, P.O. Box 22660

g.e.boeckxstaens@amc.uva.nl+31 (0)20 5667375

Outcome results