Condition category
Cancer
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr JG Freeman

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Gastroenterology & Liver Unit
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 625532

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077122803

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

04/12/2002

Overall trial end date

04/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

04/12/2002

Recruitment end date

04/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes