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

Pancreatic Tumor Clinical Trial

Official title:

Efficacy and Safety of Radiofrequency Ablation Under Endoscopic Ultrasonography Guidance in Pancreatic Neuroendocrine and Cystic Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02330497
• Other study ID #: RFAP
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: June 2018
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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) - only one session

Locations

Country	Name	City	State
France	Barthet	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the pancreatic radiofrequency ablation under EUS guidance	using the Cotton Classification	At 3 months
Secondary	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
Secondary	Safety of the pancreatic radiofrequency ablation under EUS guidance	using the Cotton Classification	At 7 days, one month, 6 and 12 months