Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Dr Colin Johnson
ORCID ID
Contact details
General Surgery
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
+44 (0)23 8079 4307
c.d.johnson@soton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 97/09/53
Study information
Scientific title
An open randomised comparison of the clinical effectiveness and costs of protocol driven opioid analgesia, celiac plexus block, or thoracoscopic splanchnicectomy for pain relief in patients with abdominal malignancy
Acronym
NaTTS
Study hypothesis
Thoracoscopic splanhnicectomy (TS) or percutaneous celiac plexus block (CPB) may reduce the need for opioids, and their side effects, and may improve quality of life in patients with painful upper GI cancer. This study aims:
1. To show better early pain relief when protocol driven opioid analgesia is supplemented with TS or CPB. This will be determined as the percentage of patients who obtain good pain relief 1 & 2 weeks after study entry (primary end point).
2. To determine the effect at 1, 2 weeks and monthly intervals until death of these interventions on opioid consumption, opioid side effects, and health related quality of life.
3. To compare survival time in the three groups of patients.
4. To evaluate total health care costs (to the hospital, community services and patient) between study entry and death in the three groups and to determine as appropriate the cost-utility, cost effectiveness or mean cost per patient of TS or CPB. From this to form an evidence based judgement of the cost-effectiveness of wider application of this new technology.
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Gastrointestinal cancer
Intervention
Protocol-driven opioid analgesia, celiac plexus block, or thoracoscopic splanchnicectomy for pain relief in patients with abdominal malignancy.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
To show better early pain relief when protocol driven opioid analgesia is supplemented with TS or CPB. This will be determined as the percentage of patients who obtain good pain relief 1 & 2 weeks after study entry (primary end point).
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/02/2002
Overall trial end date
31/10/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with gastrointestinal cancer
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
330
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/02/2002
Recruitment end date
31/10/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southampton General Hospital
Southampton
SO16 6YD
United Kingdom
Sponsor information
Organisation
University of Southampton (UK)
Sponsor details
University Road
Southampton
SO17 1BJ
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (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
Basic results (scientific)
Publication list
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/20090396