Early PEG placement in ALS patients with dysphagia is associated with longer survival, better nutritional and functional status, and better quality of life
ID
Bron
Aandoening
Patients with Amyotrophic Lateral Sclerosis (ALS) and dysphagia
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Survival
Achtergrond van het onderzoek
ALS patients with dysphagia tend to delay a PEG procedure, sometimes with evident impact on nutritional status. Nutritional status is known to be in independent prognostic factor for survival in ALS. PEG procedures in ALS patients with compromised vital capacity is not without risk. In a randomised controlled trial we include ALS patients with dysphagia (Hillel score 7 or 8) and vital capacity >65%. In arm 1 patients receive a PEG within 1 month after inclusion, in arm 2 patients wait untill either VC falls below 55%, or Hillel score is 4 or 5, or any other moment that they decide for themselves to have a PEG placed. Effects of these two strategies on survival, nutritional and functional status, and quality of life are investigated. Follow-up is 15 months.
Doel van het onderzoek
Early PEG placement in ALS patients with dysphagia is associated with longer survival, better nutritional and functional status, and better quality of life
Onderzoeksproduct en/of interventie
Early PEG (PEG placement within 4 weeks after inclusion) versus a "wait and see approach", with probably a PEG placement at a later stage
Algemeen / deelnemers
PO box 22660
M.M. Graaff, van der
Amsterdam 1100 DD
The Netherlands
+31205663647
m.m.vandergraaff@amc.uva.nl
Wetenschappers
PO box 22660
M.M. Graaff, van der
Amsterdam 1100 DD
The Netherlands
+31205663647
m.m.vandergraaff@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients with possible, probable, probable lab supported, or definite ALS;
2. Dysphagia Hillel score 7 or 8 (ALSSS dyspagia subscale);
3. Vital capacity >65%;
4. Age > 18 yr and < 85 yr;
5. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Contra-indication for PEG
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 | NL857 |
| NTR-old | NTR871 |
| Ander register | : N/A |
| ISRCTN | ISRCTN63827964 |