No registrations found.
ID
Source
Health condition
Patients with Amyotrophic Lateral Sclerosis (ALS) and dysphagia
Sponsors and support
Intervention
Outcome measures
Primary outcome
Survival
Secondary outcome
1. Vital capacity;
2. BMI;
3. Triceps skinfold;
4. ALSFRS;
5. VAS Q0L;
6. SF 36;
Background summary
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.
Study objective
Early PEG placement in ALS patients with dysphagia is associated with longer survival, better nutritional and functional status, and better quality of life
Intervention
Early PEG (PEG placement within 4 weeks after inclusion) versus a "wait and see approach", with probably a PEG placement at a later stage
PO box 22660
M.M. Graaff, van der
Amsterdam 1100 DD
The Netherlands
+31205663647
m.m.vandergraaff@amc.uva.nl
PO box 22660
M.M. Graaff, van der
Amsterdam 1100 DD
The Netherlands
+31205663647
m.m.vandergraaff@amc.uva.nl
Inclusion criteria
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.
Exclusion criteria
1. Contra-indication for PEG
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL857 |
| NTR-old | NTR871 |
| Other | : N/A |
| ISRCTN | ISRCTN63827964 |