Condition category
Cancer
Date applied
27/06/2007
Date assigned
27/06/2007
Last edited
21/09/2007
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 A.M.C.J. Voorburg

ORCID ID

Contact details

Academic Medical Centre
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 8712
a.m.voorburg@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

We want to investigate which treatment modality is better, the fentanyl patches or the Endoscopic Ultrasonography (EUS)-guided Coeliac Plexus Neurolysis (CPN). This has never been investigated before. We think that the latter treatment might be less effective than one would expect according to earlier studies.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Randomised, active controlled, crossover multicentre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pancreatic carcinoma

Intervention

Patients will be randomised according to two treatment algorithms. The first “conventional” type treatment algorithms consists of increasing dosages of transdermal fentanyl patches. In this algorithm, EUS-guided CPN (rescue) will only be performed in case of failure of opioid treatment because of insufficient pain relief (VAS score greater than or equal to 4) or unmanageable side effects. The second treatment algorithm consists of early (repeated) EUS-guided CPN. In case of insufficient pain relief after the second CPN, opioid treatment with transdermal fentanyl patches may be started. Adequate response to therapy (either after EUS-guided CPN or opioids) is defined as a pain score less than or equal to 3 on a scale from 0 - 10 (VAS score) and the absence of unmanageable opioid-related side effects.

Intervention type

Drug

Phase

Not Specified

Drug names

Transdermal fentanyl patches

Primary outcome measures

Quality of Adjusted Life Years (QALYs) will be the primary outcome parameter. This is a composite endpoint linking survival and quality of life, i.e. the number of quality adjusted life years. These are based on biweekly assessments of health status with the EuroQoL questionnaire (EQ-5D). The utility of each observed health score profile on the EQ-5D will be derived from previous research in which the time trade off based elicitation technique during interviews with adults from the general population has been applied.

Secondary outcome measures

1. Health-related quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ-C30])
2. Survival
3. Opioid requirement
4. Health status (EQ-5D)
5. Adverse effects
6. Costs

Overall trial start date

01/08/2006

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cytological or histological proven irresectable pancreatic carcinoma
2. Chronic pain unresponsive to non-opioid analgesic drugs and low dose fentanyl (Durogesic®) transdermal patches (Visual Analogue Scale [VAS] score greater than three while using fentanyl transdermal patches maximum 50 ug/h, one patch per three days)
3. Age above 18 years
4. Karnovsky score greater than 30%

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Previous coeliac plexus blockade
2. Use of opioids
3. Refusal to sign informed consent

Recruitment start date

01/08/2006

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Centre
Amsterdam
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Gastroenterology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.amc.uva.nl#http://www.amc.uva.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (The Netherlands)

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