NCT02343692

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 Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
2 countries

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
1.1 years until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

October 2, 2019

Status Verified

October 1, 2019

Enrollment Period

4.3 years

First QC Date

January 12, 2015

Last Update Submit

October 1, 2019

Conditions

Pancreatic Cyst

Outcome Measures

Primary Outcomes (1)

  • Presence of pancreatic cyst

    To evaluate pancreatic cyst ablation at 12 months following EUSguided radiofrequency ablation therapy in patients with pre-diagnosed cystic tumours of the pancreas.

    One year

Secondary Outcomes (7)

  • Mortality

    One year

  • Morbidity

    One year

  • Progression following treatment

    One year

  • Rate of surgical resection

    One year

  • Local complication rate

    One year

  • +2 more secondary outcomes

Study Arms (1)

Radiofrequency abalation

EXPERIMENTAL

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

Interventions

EUS guided RFA of cystic tumours of the pancreasPROCEDURE

Endoscopic ultrasound guided radiofrequency ablation of pancreatic cysts

Radiofrequency abalation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A diagnosis of a pancreatic cystic tumour based on multidisciplinary review of imaging, for which further surveillance with non-invasive imaging is indicated.
  • 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.
  • ECOG performance status 0, 1 or 2.
  • Estimated life expectancy of at least 12 weeks.
  • Age \>18 years.
  • Capable of giving written informed consent.
  • 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.

You may not qualify if:

  • A diagnosis of a pancreatic cystic tumour where surgical resection is indicated.
  • Pancreatic cysts greater than 3cm or less than 0.5cm in size.
  • Benign pancreatic cysts (e.g. pseudocyst).
  • Serous cystadenomas.
  • Pancreatic cysts with malignant transformation.
  • Cysts involving or in close proximity to vessels or the biliary tree where the zone of ablation is likely to compromise these structures.
  • Cysts arising from the main pancreatic duct.
  • 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).
  • Acute pancreatitis within the previous 4 weeks.
  • 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.
  • Any psychiatric disorder making reliable informed consent impossible.
  • Pregnancy or breast-feeding.
  • ECOG performance status 3 or 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Royal Melbourne Hospital, Epworth Richmond

Melbourne, Australia

RECRUITING

University Hospital Birmingham NHS FoundationTrust

Birmingham, B15 2TH, United Kingdom

RECRUITING

Glasgow Royal Infirmary

Glasgow, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Foundation Trust

Leeds, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

Royal Free London

London, NW3 2QG, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

Barts Health NHS Trust

London, United Kingdom

NOT YET RECRUITING

Homerton University Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

Kings College Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

The London Clinic

London, United Kingdom

NOT YET RECRUITING

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

NOT YET RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pancreatic Cyst

Condition Hierarchy (Ancestors)

CystsNeoplasmsPancreatic DiseasesDigestive System Diseases

Study Officials

  • Stephen P Pereira, MB BS, FRCP

    Royal Free London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bina Shah

CONTACT

situ.radiocyst@ucl.ac.uk

Chris Brew-Graves

CONTACT

situ.radiocyst@ucl.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2015

First Posted

January 22, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2020

Study Completion

August 1, 2020

Last Updated

October 2, 2019

Record last verified: 2019-10

Locations

GB(12)AU(1)