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Timing of PEG tube placement in patients with amyotrophic lateral sclerosis: soon or later?


- candidate number2408
- NTR NumberNTR871
- ISRCTNISRCTN63827964
- Date ISRCTN created8-feb-2007
- date ISRCTN requested7-feb-2007
- Date Registered NTR15-jan-2007
- Secondary IDsN/A 
- Public TitleTiming of PEG tube placement in patients with amyotrophic lateral sclerosis: soon or later?
- Scientific TitleEarlier PEG placement in ALS patients with dysphagia: effects on survival, nutritional and functional status, and quality of life
- ACRONYM
- hypothesisEarly 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) studiedDysphagia, Amyotrophic Lateral Sclerosis (ALS)
- Inclusion criteria1. 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 criteria1. Contra-indication for PEG
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 4-aug-2004
- planned closingdate
- Target number of participants20
- InterventionsEarly PEG (PEG placement within 4 weeks after inclusion) versus a "wait and see approach", with probably a PEG placement at a later stage
- Primary outcomeSurvival
- Secondary outcome1. Vital capacity; 2. BMI; 3. Triceps skinfold; 4. ALSFRS; 5. VAS Q0L; 6. SF 36;
- Timepoints
- Trial web sitenone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. M.M. Graaff, van der
- CONTACT for SCIENTIFIC QUERIESProf. Dr. M. Visser, de
- Sponsor/Initiator Academic Medical Center (AMC), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Prinses Beatrix Fonds
- PublicationsN/A
- Brief summaryALS 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)
- RECORD15-jan-2007 - 9-feb-2007


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