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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02343692




Registration number
NCT02343692
Ethics application status
Date submitted
12/01/2015
Date registered
22/01/2015
Date last updated
2/10/2019

Titles & IDs
Public title
A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas
Scientific title
A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas (RADIOCYST01)
Secondary ID [1] 0 0
13/0427
Universal Trial Number (UTN)
Trial acronym
RADIOCYST01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreatic Cyst 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - EUS guided RFA of cystic tumours of the pancreas

Experimental: Radiofrequency abalation - Intervention: Endoscopic Ultrasound (EUS) guided radiofrequency ablation (RFA) of cystic tumours of the pancreas

Device: An RFA generator (ERBE VIO 300D, Dolby medical products, Scotland)

Procedure: Delivery of sequential doses of electrical energy at 10W for a total of up to 4 minutes 30 seconds (3 x 90 second applications) to ablate the cystic lesion.

Ablation of cystic tumours of the pancreas


Treatment: Surgery: EUS guided RFA of cystic tumours of the pancreas
Endoscopic ultrasound guided radiofrequency ablation of pancreatic cysts
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Presence of pancreatic cyst
Timepoint [1] 0 0
One year
Secondary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
One year
Secondary outcome [2] 0 0
Morbidity
Timepoint [2] 0 0
One year
Secondary outcome [3] 0 0
Progression following treatment
Timepoint [3] 0 0
One year
Secondary outcome [4] 0 0
Rate of surgical resection
Timepoint [4] 0 0
One year
Secondary outcome [5] 0 0
Local complication rate
Timepoint [5] 0 0
One year
Secondary outcome [6] 0 0
Evaluation of surrogate markers of response (Imaging (CT, MRI, EUS) and serum markers.)
Timepoint [6] 0 0
One year
Secondary outcome [7] 0 0
Preliminary health economics analysis from questionnaires and cost diaries (Self-completed EQ-5D-5L questionnaire and cost diary.)
Timepoint [7] 0 0
One year

Eligibility
Key inclusion criteria
1. A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging, for which further surveillance with non-invasive imaging is indicated.
2. Pancreatic cystic tumour between 0.5 and 3cm in size. Cysts greater than 3cm or with mural nodules can be included only if patients are unsuitable for surgical resection.
3. ECOG performance status 0, 1 or 2.
4. Estimated life expectancy of at least 12 weeks.
5. Age >18 years.
6. Capable of giving written informed consent.
7. Women of child-bearing potential must have a negative pregnancy test (qualitative serum hCG) in the week before treatment, AND be using an adequate contraception method, which must be continued for at least 1 week after RF.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. A diagnosis of a pancreatic cystic tumour where surgical resection is indicated.
2. Pancreatic cysts greater than 3cm or less than 0.5cm in size.
3. Benign pancreatic cysts (e.g. pseudocyst).
4. Serous cystadenomas.
5. Pancreatic cysts with malignant transformation.
6. Cysts involving or in close proximity to vessels or the biliary tree where the zone of ablation is likely to compromise these structures.
7. Cysts arising from the main pancreatic duct.
8. History of active or prior malignancy that will interfere with the response evaluation (exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, nonmetastatic basal and/or squamous cell carcinomas of the skin, any early stage (stage l) malignancy adequately resected for cure greater than 5 years previously).
9. Acute pancreatitis within the previous 4 weeks.
10. Any evidence of severe or uncontrolled systemic diseases or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial.
11. Any psychiatric disorder making reliable informed consent impossible.
12. Pregnancy or breast-feeding.
13. ECOG performance status 3 or 4

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2020
Actual
Sample size
Target
97
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne Hospital, Epworth Richmond - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Birmingham
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Glasgow
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Leeds
Country [4] 0 0
United Kingdom
State/province [4] 0 0
London
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Newcastle-Upon-Tyne
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Other
Name
University College, London
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Up to 13.5% of patients that undergo a magnetic resonance imaging (MRI) scan of their abdomen without pancreatic symptoms are found to have an incidental pancreatic cyst, with the frequency increasing with age. In a post-mortem series, 25% of patients had a pancreatic cyst, of which 32% were potentially premalignant and 3% malignant. Premalignant cysts are currently either observed or removed surgically according to international guidelines. Observation is associated with significant anxiety for patients and a growing cost to the National Health Service, while surgery for this usually benign condition is associated with not insignificant morbidity and mortality. Premalignant pancreatic cysts may be indolent for a number of years before malignant transformation, creating a window of opportunity for minimally invasive intervention and cure. New early treatment options for premalignant tumours are urgently required. This study will evaluate the safety and efficacy of a novel minimally invasive technique for the treatment of pancreatic cystic tumours; endoscopic ultrasound guided radiofrequency ablation (EUSRFA).

If successful it will offer an alternative to long term observation or surgery for patients with this condition.
Trial website
https://clinicaltrials.gov/study/NCT02343692
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen P Pereira, MB BS, FRCP
Address 0 0
Royal Free London
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Bina Shah
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02343692