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

NCT03435770 | Unknown DMC

• 1 other identifier: 2017/2702
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Pancreatic Neoplasms; Pancreatic Adenocarcinoma; Pancreatic Neuroendocrine Tumor; Pancreatic Ductal Adenocarcinoma

Keywords

EUS-guided RFA; Endoscopic ultrasound; radio frequency ablation

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

EUSRA RFA needle

EXPERIMENTAL

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

Interventions

EUSRA RFA needle DEVICE

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.

EUSRA RFA needle

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore General Hospital: lead

Study Sites (1)

Singapore General Hospital

Singapore, 169856, Singapore

Location

Related Publications (25)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Pancreatic Neoplasms; Adenoma, Islet Cell

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Yung Ka Chin, MBChB

  Department of Gastroenterology & Herpetology, Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yung Ka Chin, MBChB

CONTACT

+6562223322; chin.yung.ka@singhealth.com.sg

Damein Tan, MBBS

CONTACT

+6562223322; damien.tan.m.y@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: prospective, open label

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 19, 2018
• Study Start: March 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: February 20, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12months after completion
• Access Criteria: Information will be made available after requestors sign a data assess agreement.

Locations

SG (1)