A randomised trial comparing argon plasma coagulation (APC) and self-expanding metal stents (SEMS) in oesophageal cancer

ISRCTN	ISRCTN58821595
DOI	https://doi.org/10.1186/ISRCTN58821595
Protocol serial number	N0077122803
Sponsor	Department of Health (UK)
Funder	Southern Derbyshire Acute Hospitals NHS Trust (UK)

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 22/09/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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 JG Freeman
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
Gastroenterology & Liver Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Phone	+44 (0)1332 625532

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	To test the hypothesis that early stent insertion is superior to argon plasma coagulation of oesophageal cancer in the palliative treatment of malignant dysphagia.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: oesophageal
Intervention	Patients not eligible for surgery, presenting with dysphagia (score of >2) will be randomised to primary treatment with either APC or SEMS. Dysphagia management will be as per randomised arm until clinical indication to crossover. Where the stricture prevents passage of the scope into the stomach, through-the-scope balloon will be performed. Either APC or stenting will be used to overcome tumour obstruction of the oesophagus. Providing the patient is able to swallow liquids after the procedure, they will be discharged for reassessment at 1 week, at which stage a second treatment can be considered to achieve a dysphagia score of 2. If this is not achieved with two treatments, crossover to stenting should be considered. Those patients who have had successful APC will attend the endoscopy unit for repeat treatments at 4 weekly intervals unless dysphagia deems earlier intervention appropriate. Stent patients will be assessed at 1 week, then monthly with quality of life questionnaires in the clinic. Patients requiring further intervention after SEMS insertion due to overgrowth would be considered for re-stenting; those with tumour ingrowth would crossover to APC. Quality of life will be quantified using EORTC QLQ-C30 and QLQ-OES, prior to intervention and at 4 weekly intervals. Dysphagia scores will be recorded prior to primary intervention, at 1 week after intervention and at 4 weekly intervals. At randomisation, length and position to tumour, histology, disease staging, body mass index and Karnofsky performance score will be recorded.
Intervention type	Other
Primary outcome measure(s)	1. Comparison of reductions in dysphagia scores between the two groups 2. Comparison of quality of life scores between the two groups 3. Number of interventions per arm and consequent cost analysis
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	04/12/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Patients with oesophageal cancer who are not eligible for surgery following multi-disciplinary team discussion who are unable to swallow semi-solid food
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	04/12/2002
Date of final enrolment	04/12/2005

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE22 3NE
United Kingdom

Results and Publications

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