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A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas (RADIOCYST01)

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ClinicalTrials.gov Identifier: NCT02343692
Recruitment Status : Recruiting
First Posted : January 22, 2015
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University College, London

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.


Condition or disease Intervention/treatment Phase
Pancreatic Cyst Procedure: EUS guided RFA of cystic tumours of the pancreas Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 97 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Multicentre Trial of Endoscopic Ultrasound Guided Radiofrequency Ablation of Cystic Tumours of the Pancreas (RADIOCYST01)
Actual Study Start Date : March 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Procedure: EUS guided RFA of cystic tumours of the pancreas
Endoscopic ultrasound guided radiofrequency ablation of pancreatic cysts




Primary Outcome Measures :
  1. Presence of pancreatic cyst [ Time Frame: One year ]
    To evaluate pancreatic cyst ablation at 12 months following EUSguided radiofrequency ablation therapy in patients with pre‐diagnosed cystic tumours of the pancreas.


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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02343692


Contacts
Contact: Bina Shah situ.radiocyst@ucl.ac.uk
Contact: Chris Brew-Graves situ.radiocyst@ucl.ac.uk

Locations
Australia
Royal Melbourne Hospital, Epworth Richmond Recruiting
Melbourne, Australia
Contact: Andrew Metz         
Principal Investigator: Andrew Metz, MBBS, FRACP         
United Kingdom
University Hospital Birmingham NHS FoundationTrust Recruiting
Birmingham, United Kingdom, B15 2TH
Principal Investigator: Brinder Mahon, MD         
Glasgow Royal Infirmary Recruiting
Glasgow, United Kingdom
Principal Investigator: Lyn Smith, MD         
Leeds Teaching Hospitals NHS Foundation Trust Recruiting
Leeds, United Kingdom
Principal Investigator: Matthew Huggett, MD         
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom, NW1 2PG
Principal Investigator: Stephen P Periera, MB BS, FRCP         
Royal Free London Recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: Stephen P Pereira, MB BS, FRCP         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W2 1NY
Principal Investigator: Nagy Habib, MD         
Barts Health NHS Trust Not yet recruiting
London, United Kingdom
Principal Investigator: Patrick Wilson, MD         
Homerton University Hospital NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Ray Shidrawi, MD         
Kings College Hospital NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: John Devlin, MD         
Sub-Investigator: Mayur Kumar, MD         
The London Clinic Not yet recruiting
London, United Kingdom
Principal Investigator: Steve Pereira, MD         
The Newcastle Upon Tyne Hospitals NHS Foundation Trust Not yet recruiting
Newcastle-Upon-Tyne, United Kingdom, NE7 7DN
Principal Investigator: Kofi Oppong, MD         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG7 2UH
Principal Investigator: Suresh Vasan Venkatachalapathy, MD         
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Stephen P Pereira, MB BS, FRCP Royal Free London

Additional Information:
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02343692     History of Changes
Other Study ID Numbers: 13/0427
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Pancreatic Cyst
Pancreatic Neoplasms
Cysts
Neoplasms
Pancreatic Diseases
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Pancrelipase
Pancreatin
Gastrointestinal Agents