Efficacy and Safety of Radiofrequency Ablation in Pancreatic Neuroendocrine and Cystic Tumor
Condition: Pancreatic Tumor; Endocrine Tumor; Neoplasms, Cystic, Mucinous, and Serous
MeSH terms: Neoplasms; Pancreatic Neoplasms; Endocrine Gland Neoplasms; Neoplasms, Cystic, Mucinous, and Serous
Study type: Interventional

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.
    


Intervention name(s): Radiofrequency Ablation under EUS
Intervention type(s): Procedure
Intervention description(s): 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
Other intervention name(s): Radiofrequency
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment