Pancreatic Cancer Clinical Trial
Official title:
Evaluation of Safety and Feasibility of Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) for Solid Pancreatic Neoplasms
This study aims to evaluate the safety and efficacy of new ablation catheter developed by MEDICAL TAEWOONG for the treatment of pancreatic neoplasm (pancreatic adenocarcinoma or neuroendocrine tumour). The ablation is performed using EUSRA needle and radio frequency waves under ultrasound imaging. The subject who will be recruited into this study are patients who are deemed as non-surgical candidates.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | September 1, 2019 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 99 Years |
Eligibility |
Inclusion Criteria: - Age 21 years-old or above - Suffering from pancreatic neuroendocrine tumour or pancreatic ductal carcinoma that was confirmed by fine needle aspiration cytology - Unsuitable for surgery, due to one (or more) of the following items: - ASA score >/= III - An alternative advanced malignancy - Unsuitable for surgery upon expert's opinion for any other reason - Individuals who are not keen for surgical resection - Eligible for endoscopic intervention - Written informed consent Exclusion Criteria: - Coagulopathy (international normalized ratio >1.5, partial thromboplastin time greater than twice that of control), platelet count <50,000x103/uL - Pregnancy - Patients with a poor mental condition or mental retardation, unable to understand the nature and possible consequences of the study - Patients unwilling to undergo follow-up assessments - Patients with liver cirrhosis, portal hypertension and/or gastric varices. |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
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Arcidiacono PG, Carrara S, Reni M, Petrone MC, Cappio S, Balzano G, Boemo C, Cereda S, Nicoletti R, Enderle MD, Neugebauer A, von Renteln D, Eickhoff A, Testoni PA. Feasibility and safety of EUS-guided cryothermal ablation in patients with locally advanced pancreatic cancer. Gastrointest Endosc. 2012 Dec;76(6):1142-51. doi: 10.1016/j.gie.2012.08.006. Epub 2012 Sep 26. — View Citation
Bai H, Huangz X, Jing L, Zeng Q, Han L. The effect of radiofrequency ablation vs. liver resection on survival outcome of colorectal liver metastases (CRLM): a meta-analysis. Hepatogastroenterology. 2015 Mar-Apr;62(138):373-7. Review. — View Citation
Carrara S, Arcidiacono PG, Albarello L, Addis A, Enderle MD, Boemo C, Campagnol M, Ambrosi A, Doglioni C, Testoni PA. Endoscopic ultrasound-guided application of a new hybrid cryotherm probe in porcine pancreas: a preliminary study. Endoscopy. 2008 Apr;40(4):321-6. doi: 10.1055/s-2007-995595. — View Citation
Carrara S, Arcidiacono PG, Albarello L, Addis A, Enderle MD, Boemo C, Neugebauer A, Campagnol M, Doglioni C, Testoni PA. Endoscopic ultrasound-guided application of a new internally gas-cooled radiofrequency ablation probe in the liver and spleen of an animal model: a preliminary study. Endoscopy. 2008 Sep;40(9):759-63. doi: 10.1055/s-2008-1077520. Epub 2008 Aug 13. — View Citation
Chu KF, Dupuy DE. Thermal ablation of tumours: biological mechanisms and advances in therapy. Nat Rev Cancer. 2014 Mar;14(3):199-208. doi: 10.1038/nrc3672. Review. — View Citation
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Elias D, Baton O, Sideris L, Lasser P, Pocard M. Necrotizing pancreatitis after radiofrequency destruction of pancreatic tumours. Eur J Surg Oncol. 2004 Feb;30(1):85-7. — View Citation
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Keane MG, Bramis K, Pereira SP, Fusai GK. Systematic review of novel ablative methods in locally advanced pancreatic cancer. World J Gastroenterol. 2014 Mar 7;20(9):2267-78. doi: 10.3748/wjg.v20.i9.2267. Review. — View Citation
Kim HJ, Seo DW, Hassanuddin A, Kim SH, Chae HJ, Jang JW, Park DH, Lee SS, Lee SK, Kim MH. EUS-guided radiofrequency ablation of the porcine pancreas. Gastrointest Endosc. 2012 Nov;76(5):1039-43. doi: 10.1016/j.gie.2012.07.015. — View Citation
Liu SY, Ng EK, Lee PS, Wong SK, Chiu PW, Mui WL, So WY, Chow FC. Radiofrequency ablation for benign aldosterone-producing adenoma: a scarless technique to an old disease. Ann Surg. 2010 Dec;252(6):1058-64. doi: 10.1097/SLA.0b013e318f66936. — View Citation
Matsui Y, Nakagawa A, Kamiyama Y, Yamamoto K, Kubo N, Nakase Y. Selective thermocoagulation of unresectable pancreatic cancers by using radiofrequency capacitive heating. Pancreas. 2000 Jan;20(1):14-20. — View Citation
McGahan JP, Browning PD, Brock JM, Tesluk H. Hepatic ablation using radiofrequency electrocautery. Invest Radiol. 1990 Mar;25(3):267-70. — View Citation
Pai M, Senturk H, Lakhtakia S, Reddy DN, Cicinnati C, Kabar I, Beckebaum S, Jin Z, Wang D, Yang J, et al. Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Cystic Neoplasms and Neuroendocrine Tumours of the Pancreas. Gastrointest Endosc. 2013;77(5S): AB143-AB144
Qi X, Tang Y, An D, Bai M, Shi X, Wang J, Han G, Fan D. Radiofrequency ablation versus hepatic resection for small hepatocellular carcinoma: a meta-analysis of randomized controlled trials. J Clin Gastroenterol. 2014 May-Jun;48(5):450-7. doi: 10.1097/MCG.0000000000000008. Review. — View Citation
Rossi S, Fornari F, Pathies C, Buscarini L. Thermal lesions induced by 480 KHz localized current field in guinea pig and pig liver. Tumori. 1990 Feb 28;76(1):54-7. — View Citation
Smith SL, Jennings PE. Lung radiofrequency and microwave ablation: a review of indications, techniques and post-procedural imaging appearances. Br J Radiol. 2015 Feb;88(1046):20140598. doi: 10.1259/bjr.20140598. Epub 2014 Dec 3. Review. — View Citation
Song TJ, Seo DW, Lakhtakia S, Reddy N, Oh DW, Park DH, Lee SS, Lee SK, Kim MH. Initial experience of EUS-guided radiofrequency ablation of unresectable pancreatic cancer. Gastrointest Endosc. 2016 Feb;83(2):440-3. doi: 10.1016/j.gie.2015.08.048. Epub 2015 Sep 4. — View Citation
Spiliotis JD, Datsis AC, Michalopoulos NV, Kekelos SP, Vaxevanidou A, Rogdakis AG, Christopoulou AN. Radiofrequency ablation combined with palliative surgery may prolong survival of patients with advanced cancer of the pancreas. Langenbecks Arch Surg. 2007 Jan;392(1):55-60. Epub 2006 Nov 7. — View Citation
Varadarajulu S, Jhala NC, Drelichman ER. EUS-guided radiofrequency ablation with a prototype electrode array system in an animal model (with video). Gastrointest Endosc. 2009 Aug;70(2):372-6. doi: 10.1016/j.gie.2009.03.008. Epub 2009 Jun 26. — View Citation
Wu Y, Tang Z, Fang H, Gao S, Chen J, Wang Y, Yan H. High operative risk of cool-tip radiofrequency ablation for unresectable pancreatic head cancer. J Surg Oncol. 2006 Oct 1;94(5):392-5. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the technical success of EUS-guided RFA | It is defined as successful puncture of the pancreatic lesion with the RFA needle and completion of the ablation cycle. | 18 months | |
Primary | To measure side effects and adverse event of EUS-guided RFA | Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events (PB Cotton GIE 2010). Potential adverse events specific to RFA include: Post-RFA syndrome: Combination of flu like symptoms including fever, malaise, pain at the site of ablation, nausea, and/or vomiting and that no other septic source is identified. Pancreatitis: Clinical presence of abdominal pain with an increase in amylase level >3 times above the normal serum amylase levels. Pancreatic leak: The presence of an abdominal collection with an amylase level that is >3 times normal serum amylase levels. Thermal injury: Coagulative necrosis occurring at the site of needle entry within the gastrointestinal tract with or without clinical sequelae. |
18 months |
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