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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Radiofrequency Ablation under EUS
Sponsored by
Société Française d'Endoscopie Digestive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Tumor

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Barthet

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiofrequency

Arm Description

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

Outcomes

Primary Outcome Measures

Safety of the pancreatic radiofrequency ablation under EUS guidance
using the Cotton Classification

Secondary Outcome Measures

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
Safety of the pancreatic radiofrequency ablation under EUS guidance
using the Cotton Classification

Full Information

First Posted
December 20, 2014
Last Updated
June 10, 2018
Sponsor
Société Française d'Endoscopie Digestive
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1. Study Identification

Unique Protocol Identification Number
NCT02330497
Brief Title
Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor
Official Title
Efficacy and Safety of Radiofrequency Ablation Under Endoscopic Ultrasonography Guidance in Pancreatic Neuroendocrine and Cystic Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Société Française d'Endoscopie Digestive

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Tumor, Endocrine Tumor, Neoplasms, Cystic, Mucinous, and Serous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency
Arm Type
Experimental
Arm Description
Procedure/Surgery Thermal Radiofrequency Ablation under endoscopic ultrasonography guidance of the pancreatic neuro endocrine tumor or mucinous cyst.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation under EUS
Other Intervention Name(s)
Radiofrequency
Intervention Description
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) - only one session
Primary Outcome Measure Information:
Title
Safety of the pancreatic radiofrequency ablation under EUS guidance
Description
using the Cotton Classification
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Efficiency of the pancreatic radiofrequency ablation under EUS guidance
Description
Decrease of the size of the lesion using CT-scan and tumoral response using the Response Evaluation Criteria in Solid Tumors criterion
Time Frame
At month 6 and 12
Title
Safety of the pancreatic radiofrequency ablation under EUS guidance
Description
using the Cotton Classification
Time Frame
At 7 days, one month, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Barthet, MD, PhD
Organizational Affiliation
Assistance Publique des hôpitaux de Marseille
Official's Role
Study Chair
Facility Information:
Facility Name
Barthet
City
Marseille
ZIP/Postal Code
13000
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
30669161
Citation
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.
Results Reference
derived

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

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