NCT04520932

Brief Summary

Pancreatic radiofrequency ablation (RFA) could therefore be an alternative to the monitoring of pancreatic neuroendocrine tumors (PNETs) and more particularly nonfunctioning PNETs (NF-PNETs), which is costly and anxiety-inducing for patients. To date, only a few small studies have evaluated this treatment and the results are encouraging. It appears necessary to consider a large-scale study to ensure the efficacy and low morbidity of pancreatic RFA applied to PNETs.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
60mo left

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress51%
Mar 2021Apr 2031

First Submitted

Initial submission to the registry

August 17, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

March 30, 2021

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2031

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

6 years

First QC Date

August 17, 2020

Last Update Submit

May 23, 2025

Conditions

Neuroendocrine Tumor of Pancreas (Disorder)Neuroendocrine Tumor Grade 1

Keywords

Radio Frequency treatmentEchoendoscopyAblationEfficacy

Outcome Measures

Primary Outcomes (1)

  • Treatment response

    Complete response rate to radiofrequency treatment defined by the absence of enhancement with the contrast agent and/or the disappearance of the lesion on imaging.

    1 year

Study Arms (1)

RFA treatment efficacy

EXPERIMENTAL

PNETs ablation by radiofrequency treatment (1 to 3 sessions)

Procedure: Radiofrequency ablation

Interventions

Radiofrequency ablationPROCEDURE

RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.

RFA treatment efficacy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pancreatic mass of less than 2cm on MRI, or CT scan if contraindicated by MRI;
  • Diagnosis of neuroendocrine tumor on biopsy under high echo-endoscopy (HEE) with Ki67\<3%,
  • Non-secretory lesion.
  • Homogeneous HEE contrast taking;
  • No positron emission tomography (PET) FDG binding to the pancreatic mass;
  • Lesion \<20mm on conventional imaging at 6 months monitoring;
  • Age 18 to 80 years inclusive;
  • Patient in good general condition, World Health Organization \[0-1\];
  • Signed consent to participate;
  • Affiliation to healthcare insurance system or beneficiary of this regimen.

You may not qualify if:

  • Pregnant or likely to become pregnant (without effective contraception) or breastfeeding ;
  • A person in an emergency situation or deprived of liberty or placed under the authority of a tutor.
  • Life expectancy \< 1 year;
  • Severe hemostasis disorders;
  • Pancreatic and/or biliary ductal dilation;
  • Lesion considered to be adjacent to the pancreatic duct and/or bile duct;
  • Node extension and/or metastatic disease;
  • Patient being managed for another malignant lesion which is progressive or under treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

RECRUITING

MeSH Terms

Conditions

Adenoma, Islet Cell

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPancreatic NeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Fabrice CAILLOL, MD

    Paoli Calmettes Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jihane PAKRADOUNI

CONTACT

+33491223778drci.up@ipc.unicancer.fr

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

August 17, 2020

First Posted

August 20, 2020

Study Start

March 30, 2021

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2031

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)