Inoperable oesophageal cancer - stent or percutaneous endoscopically placed gastrostomy (PEG). Randomised trial to compare the risks and benefits of expanding metallic stent and PEG in inoperable oesophageal cancer

ISRCTN	ISRCTN95850244
DOI	https://doi.org/10.1186/ISRCTN95850244
Protocol serial number	N0084096607
Sponsor	Department of Health (UK)
Funder	The North and South Bank Research and Development Consortium (UK)

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

Dr Mounes Dakkak
Scientific

Hull Royal Infirmary
Anlaby Road
Hull
HU3 2JZ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	1. Does the early placement of a PEG feeding tube prolong life and/or improve quality of life? 2. Does PEG feeding offer advantages over stent placement?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Oesophageal
Intervention	1. Oesophageal stent 2. PEG Please note that this trial was stopped due to participant recruitment issues.
Intervention type	Other
Primary outcome measure(s)	Survival and quality of life.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/2003
Reason abandoned (if study stopped)	Participant recruitment issue

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	40
Key inclusion criteria	20 patients for each study arm.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2000
Date of final enrolment	30/06/2003

Hull Royal Infirmary

Hull
HU3 2JZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan