Valved oesophageal stents in patients with oesophageal carcinoma.

ISRCTN	ISRCTN78960892
DOI	https://doi.org/10.1186/ISRCTN78960892
Protocol serial number	N0013160111
Sponsor	Department of Health
Funders	Guy's and St. Thomas' NHS Foundation Trust (UK), Own account, NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Andreas Adam
Scientific

Department of Radiology
F01 Lambeth Wing
St Thomas's Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Phone	+44 (0)20 7188 5550
Email	andy.adam@kcl.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Whether a valve in oesophageal stent design is beneficial?
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Oesophageal cancer
Intervention	Following stent insertion, symptomatic reflux may occur, to evaluate whether a valve may prevent this we are conducting this randomised controlled trial comparing valveless stents versus a stent with a valve. All patients entered into this study will have cancer obstructing the lower oesophagus and will be treated with metallic stents projecting into the stomach. There are two groups: One group will receive stents that have a valve that is designed to prevent stomach contents reaching the oesophagus. The other will have stents without a valve. We will look at how well the stents work at stopping reflux, how well they receive dysphagia (difficulty in swallowing) and what the complications are in each group. Subjects will be randomised using a book of random numbers.
Intervention type	Other
Primary outcome measure(s)	Dysphagia scores, barium reflux.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	27/01/2006

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	Randomised between stents with no valve but prescribed Omeprazole and stent with valve. Approx. 50 patients.
Key exclusion criteria	1. Pregnant women 2. Patients under 18 years of age 3. Patients unfit for stent insertion
Date of first enrolment	27/01/2005
Date of final enrolment	27/01/2006

Department of Radiology

London
SE1 7EH
United Kingdom

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes