Health TrialsbyHealthPanel

EUS-guided RFA for Pancreatic Neoplasms

ConditionPancreatic Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

Radiofrequency ablation has been used for treatment of solid neoplasms of the liver, lung, kidney and adrenal. Recently, EUS-guided RFA has become available and the device allows EUS-guided treatment of pancreatic neoplasms. The procedure has been shown to be feasible in the porcine pancreas and was used to treat small groups of patients that are not suitable for surgery suffering from pancreatic neoplasms.

The aim of the current study is to perform a multi-center prospective study on EUS-guided radiofrequency ablation (RFA) of solid pancreatic neoplasms. The hypothesis is that EUS-guided RFA is safe, feasible and effective for treating solid pancreatic neoplasms.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18 years-old or above

Suffering from pancreatic neuroendocrine tumor or pancreatic ductal carcinoma (<5cm in largest diameter) that was confirmed by fine needle aspiration cytology

ASA score > II*

An alternative advanced malignancy

Disqualifiers

Coagulopathy (international normalized ratio >1.3, 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

Trial design

Design model

Single group

Treatments tested in this trial

  • EUS-guided RFA

    Procedure/Surgery

    EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: EUS-guided RFAExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Severe adverse events

Adverse events specific to RFA would be graded according to the lexicon of endoscopic adverse events 24. Potential adverse events specific to RFA include: post-RFA syndrome, pancreatitis, pancreatic leak, thermal injury

Time frame
30 days

Secondary outcomes

1

Technical success rates

defined as successful puncture of the lesion with the RFA needle and completion of the ablation cycle.

Time frame
1 week
2

Procedural times

Duration of the procedure

Time frame
1 day
3

Hospital stay

Duration of hospital stay

Time frame
30 days
4

Radiological response

Based on modified RECIST criterion

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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