Timing of percutaneous endoscopic gastrostomy tube placement in patients with amyotrophic lateral sclerosis: sooner or later?
| ISRCTN | ISRCTN63827964 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63827964 |
| Protocol serial number | NL857 (NTR871) |
| Sponsor | Academic Medical Centre (AMC) (The Netherlands) |
| Funder | Prinses Beatrix Fonds (The Netherlands) |
- Submission date
- 08/02/2007
- Registration date
- 08/02/2007
- Last edited
- 20/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M M van der Graaff
Scientific
Scientific
Academic Medical Centre
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Phone | +31 (0)20 566 3647 |
|---|---|
| m.m.vandergraaff@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active-controlled, parallel group, multicentre trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Earlier PEG placement in ALS patients with dysphagia: effects on survival, nutritional and functional status, and quality of life |
| Study objectives | Early Percutaneous Endoscopic Gastrostomy (PEG) placement in Amyotrophic Lateral Sclerosis (ALS) patients with dysphagia is associated with longer survival, better nutritional and functional status, and better quality of life. |
| Ethics approval(s) | Approval received from the Medical Ethical Committee of Academic Medical Centre on the 19th March 2003 (ref: MEC 02/184). |
| Health condition(s) or problem(s) studied | Amyotrophic Lateral Sclerosis (ALS), Dysphagia |
| Intervention | Arm one: patients receive a PEG within one month after inclusion Arm two: patients wait untill either VC falls below 55%, or Hillel score is four or five, 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 in 15 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Survival. |
| Key secondary outcome measure(s) |
1. Vital capacity |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Patients with possible, probable, probable laboratory supported, or definite ALS 2. Dysphagia Hillel score seven or eight (ALS Severity Scale [ALSSS] dysphagia subscale) 3. Vital Capacity (VC) more than 65% 4. Aged more than 18 years and less than 85 years 5. Informed consent |
| Key exclusion criteria | 1. Contra-indications for PEG |
| Date of first enrolment | 04/08/2004 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Centre
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/08/2021: Proactive update review. No publications found. Search options exhausted.
