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
Secondary identifying numbers	NL857 (NTR871)

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

Academic Medical Centre
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 3647
Email	m.m.vandergraaff@amc.uva.nl

Study information

Study design	Randomised, active-controlled, parallel group, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
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	Survival.
Secondary outcome measures	1. Vital capacity 2. Body Mass Index (BMI) 3. Triceps skinfold 4. ALS Functional Rating Scale (ALSFRS) 5. Visual Analogue Scale for Quality of Life (VAS QoL) 6. Short Form health survey (SF 36)
Overall study start date	04/08/2004
Completion date	01/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	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

Sponsor information

Academic Medical Centre (AMC) (The Netherlands)
Hospital/treatment centre

Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Website	http://www.amc.uva.nl/#http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Research organisation

Prinses Beatrix Fonds (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/08/2021: Proactive update review. No publications found. Search options exhausted.