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

NCT02343692 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2019-10-02

No results posted yet for this study

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.

Conditions

  • Pancreatic Cyst

Interventions

PROCEDURE

EUS guided RFA of cystic tumours of the pancreas

Endoscopic ultrasound guided radiofrequency ablation of pancreatic cysts

Sponsors & Collaborators

  • University College, London

    lead OTHER

Principal Investigators

  • Stephen P Pereira, MB BS, FRCP · Royal Free London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2020-06-30
Completion
2020-08-31

Countries

  • Australia
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02343692 on ClinicalTrials.gov