| - candidate number | 2408 |
| - NTR Number | NTR871 |
| - ISRCTN | ISRCTN63827964 |
| - Date ISRCTN created | 8-feb-2007 |
| - date ISRCTN requested | 7-feb-2007 |
| - Date Registered NTR | 15-jan-2007 |
| - Secondary IDs | N/A |
| - Public Title | Timing of PEG tube placement in patients with amyotrophic lateral sclerosis: soon or later? |
| - Scientific Title | Earlier PEG placement in ALS patients with dysphagia: effects on survival, nutritional and functional status, and quality of life |
| - ACRONYM | |
| - hypothesis | Early PEG placement in ALS patients with dysphagia is associated with longer survival, better nutritional and functional status, and better quality of life |
| - Healt Condition(s) or Problem(s) studied | Dysphagia, Amyotrophic Lateral Sclerosis (ALS) |
| - 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 |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 4-aug-2004 |
| - planned closingdate | |
| - Target number of participants | 20 |
| - Interventions | Early PEG (PEG placement within 4 weeks after inclusion) versus a "wait and see approach", with probably a PEG placement at a later stage |
| - Primary outcome | Survival |
| - Secondary outcome | 1. Vital capacity; 2. BMI; 3. Triceps skinfold; 4. ALSFRS; 5. VAS Q0L; 6. SF 36; |
| - Timepoints | |
| - Trial web site | none |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Dr. M.M. Graaff, van der |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. M. Visser, de |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Neurology |
| - Funding (Source(s) of Monetary or Material Support) | Prinses Beatrix Fonds |
| - Publications | N/A |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 15-jan-2007 - 9-feb-2007 |
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