N/A
ID
Bron
Verkorte titel
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Symptom control;<br>
2. Therapeutic succes.
Achtergrond van het onderzoek
Multi-center study; Subjects will be followed during several years, as long as possible. 1 month after treatment a manometry and an esophageal emptying will be performed and will be repeated every year. 1 year after treatment
an endoscopy (+ Lugol staining) and 24h pH metry will be performed and will be repeated every 3 years.
Doel van het onderzoek
N/A
Onderzoeksopzet
Every year.
Onderzoeksproduct en/of interventie
The major aim of this prospective, randomized, multi-center study is to compare the two treatments, namely pneumatic dilation and laparoscopic Heller myotomy.
Publiek
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
G.E.E. Boeckxstaens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5667375
g.e.boeckxstaens@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Between 18-75 yr of age, manometric diagnosis of achalasia, Eckardt score >3, signed informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL17 |
| NTR-old | NTR37 |
| Ander register | : N/A |
| ISRCTN | ISRCTN56304564 |
Samenvatting resultaten
Heller’s Myotomy for Idiopathic Achalasia<br>
Guy E. Boeckxstaens, M.D., Ph.D., Vito Annese, M.D., Ph.D., Stanislas Bruley des Varannes, M.D., Ph.D., Stanislas Chaussade, M.D., Ph.D., Mario Costantini, M.D., Ph.D., Antonello Cuttitta, M.D., J. Ignasi Elizalde, M.D., Uberto Fumagalli, M.D., Ph.D., Marianne Gaudric, M.D., Ph.D., Wout O. Rohof, M.D., André J. Smout, M.D., Ph.D., Jan Tack, M.D., Ph.D., Aeilko H. Zwinderman, Ph.D., Giovanni Zaninotto, M.D., Ph.D., and Olivier R. Busch, M.D., Ph.D., for the European Achalasia Trial Investigators<br>
n engl j med 364;19 nejm.org may 12, 2011