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Evaluation of Safety and Feasibility of EUS-guided RFA for Solid Pancreatic Neoplasms

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ClinicalTrials.gov Identifier: NCT03435770
Recruitment Status : Not yet recruiting
First Posted : February 16, 2018
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Chin Yung Ka, Singapore General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Pancreatic Neoplasms Pancreatic Adenocarcinoma Pancreatic Neuroendocrine Tumor Pancreatic Ductal Adenocarcinoma Device: EUSRA RFA needle Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: prospective, open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Feasibility of Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA) for Solid Pancreatic Neoplasms
Estimated Study Start Date : March 1, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 1, 2019


Arm Intervention/treatment
Experimental: EUSRA RFA needle
This procedure is very similar to the standard technique of EUS-guided fine needle aspiration. All patients would undergo EUS with a linear array or therapeutic echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the EUSRA RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue.
Device: EUSRA RFA needle
A 19-gauge RFA electrode and a RF generator with a electrode that is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds. Sequential applications of up to 7 times per session are allowed for complete ablation of the lesions.




Primary Outcome Measures :
  1. To measure the technical success of EUS-guided RFA [ Time Frame: 18 months ]
    It is defined as successful puncture of the pancreatic lesion with the RFA needle and completion of the ablation cycle.

  2. To measure side effects and adverse event of EUS-guided RFA [ Time Frame: 18 months ]

    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.



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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435770


Contacts
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Contact: Yung Ka Chin, MBChB +6562223322 chin.yung.ka@singhealth.com.sg
Contact: Damein Tan, MBBS +6562223322 damien.tan.m.y@singhealth.com.sg

Locations
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Singapore
Singapore General Hospital
Singapore, Singapore, 169856
Sponsors and Collaborators
Singapore General Hospital
Investigators
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Principal Investigator: Yung Ka Chin, MBChB Department of Gastroenterology & Herpetology, Singapore General Hospital

Publications:
1. Pai M, Yang J, Zhang X, Jin Z, Wang D, Senturk H, Lakhtakia S, Reddy DN, Kahaleh M, Habib N, et al. Endoscopic ultrasound guided radiofrequency ablation (EUS-RFA) for pancreatic ductal adenocarcinoma. Gut. 2013;62(Suppl 1):A153.
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

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Responsible Party: Chin Yung Ka, Principal Investigator, Singapore General Hospital
ClinicalTrials.gov Identifier: NCT03435770     History of Changes
Other Study ID Numbers: 2017/2702
First Posted: February 16, 2018    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD on study protocol will be made available
Supporting Materials: Study Protocol
Time Frame: 12months after completion
Access Criteria: Information will be made available after requestors sign a data assess agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chin Yung Ka, Singapore General Hospital:
EUS-guided RFA
Endoscopic ultrasound
radio frequency ablation
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Neuroendocrine Tumors
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue