Efficacy And Safety Of Radiofrequency Ablation In Pancreatic Neuroendocrine And Cystic Tumor

Study Overview

Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor

Advances in conventional imaging (abdominal ultrasound, CT scan, MRI) are so great that chance to discover a incidental solid or cystic pancreatic lesion is becoming usual. Endocrine tumors have variable malignant potential depending on their size, some malignancy for lesions larger than 2 cm and indefinite for a smaller size. The branch-duct like IPMN (intraductal papillary mucinous pancreatic tumor) involving the pancreatic secondary ducts represent half of pancreatic cystic tumors and may degenerate into 5 to 10% of cases. Signs and risk of degeneration are the presence of mural nodules greater than 5 mm and size > 3 cm, although the latter criterion is discussed. Mucinous cystadenomas could degenerate between 30 and 50% of cases even though the role of size is much discussed (<4 cm). The follow-up imaging is performed using MRI and endoscopic ultrasonography (EUS). A fine needle aspiration for cytology and histology is possible and determination of biological markers is useful. But cytology is often unprofitable due to the poor cellular profile of the cystic pancreatic tumor. Once the diagnosis of suspected malignancy, the patient should be referred to the surgeon for pancreatic resection more or less extensive. But this attitude is facing a significant operative risk with up to 30% of morbidity and mortality between 1 and 3 % for cephalic resections. Some patients with high post operative risks are inoperable. For these reasons, some teams have proposed the destruction of the walls of the cyst under EUS, US or CT control by washing with absolute alcohol content of cystic tumor. An interesting alternative endoscopic destruction would be the use of radio frequency ablation technique (RFA). RFA is a recognized technique for local tumor destruction by delivering thermal energy to obtain coagulation necrosis of the lesion. Taewong Medical ™ recently developed a radiofrequency needle EUSRA® coupled with a combo VIVA ™ generator for applying RFA sub EUS control. But no prospective study is available at this date regarding the treatment of the cystic or solid tumoral pancreatic lesion with this technique. The primary endpoint of the present study is to investigate the feasibility and safety of this guided radiofrequency probe EUS for the treatment of pancreatic endocrine tumors or inoperable pancreatic cystic tumors. The secondary objective will be the efficiency.

N/A

Pancreatic Tumor
Endocrine Tumor
Neoplasms, Cystic, Mucinous, and Serous

PROCEDURE: Radiofrequency Ablation under EUS

RFAP

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2014-12-20	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-06-10
First Submitted that Met QC Criteria 2014-12-31	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-06-12
First Posted (ACTUAL) 2015-01-05	Results First Posted N/A	Last Verified 2018-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Radiofrequency Procedure/Surgery Thermal Radiofrequency Ablation under endoscopic ultrasonography guidance of the pancreatic neuro endocrine tumor or mucinous cyst.	PROCEDURE: Radiofrequency Ablation under EUS Pancreatic radiofrequency ablation under endoscopic ultrasonography guidance Procedure under general anesthesia Punction of the pancreatic lesion and aspiration of the liquid if present / then thermal ablation with a 18G needle (50 W during 10 secondes) -

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Radiofrequency

Procedure/Surgery Thermal Radiofrequency Ablation under endoscopic ultrasonography guidance of the pancreatic neuro endocrine tumor or mucinous cyst.

PROCEDURE: Radiofrequency Ablation under EUS

Pancreatic radiofrequency ablation under endoscopic ultrasonography guidance Procedure under general anesthesia Punction of the pancreatic lesion and aspiration of the liquid if present / then thermal ablation with a 18G needle (50 W during 10 secondes) -

Primary Outcome Measures	Measure Description	Time Frame
Safety of the pancreatic radiofrequency ablation under EUS guidance	using the Cotton Classification	At 3 months

Secondary Outcome Measures	Measure Description	Time Frame
Efficiency of the pancreatic radiofrequency ablation under EUS guidance	Decrease of the size of the lesion using CT-scan and tumoral response using the Response Evaluation Criteria in Solid Tumors criterion	At month 6 and 12
Safety of the pancreatic radiofrequency ablation under EUS guidance	using the Cotton Classification	At 7 days, one month, 6 and 12 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Pancreatic neuro endocrine tumor <2 cm confirmed by pathological reading, or mucinous cystic tumor (branch duct like IPMN with nodule wall > 5 mm unresectable) or mucinous cystadenoma with unresectable wall thickening
Unresectable patient or high operative risk
Multidisciplinary Collaborative Meeting confirming the indication for treatment.
Patients who consented to participate in the study
American Society Anesthesiology classification 1, 2 or 3
Patient affiliated to the national social security system (beneficiary or assignee)

Invasive carcinoma lesions in a patient whose clinical condition allows to consider a surgical pancreatic resection
Severe coagulopathy (PT <50%, partial thromboplastin time > 42 sec), thrombocytopenia (<75,000 G/L), antiplatelets agent
Patient under anticoagulant agent (NACO, heparin and warfarin)
American Society Anesthesiology classification 4
Patient belonging to a so-called vulnerable patient population (pregnancy, nursing, patient trust, guardianship, private patient freedom, ...)
Women of childbearing age, including in contraception
Pace maker
Inability to obtain informed consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Marc Barthet, MD, PhD, Assistance Publique des hôpitaux de Marseille

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Barthet M, Giovannini M, Lesavre N, Boustiere C, Napoleon B, Koch S, Gasmi M, Vanbiervliet G, Gonzalez JM. Endoscopic ultrasound-guided radiofrequency ablation for pancreatic neuroendocrine tumors and pancreatic cystic neoplasms: a prospective multicenter study. Endoscopy. 2019 Sep;51(9):836-842. doi: 10.1055/a-0824-7067. Epub 2019 Jan 22.

Learn

Resources

Patients

Caregivers

Clinical Trial Record