Condition category
Cancer
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
05/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.soton.ac.uk/

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

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/20090396

Publication citations

Additional files

Editorial Notes

On 04/09/2009 the overall trial start and end dates were changed from 01/02/2001 and 31/01/2004 to 01/02/2002 and 31/10/2005, respectively.