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EUS-RFA for Unresectable Pancreatic Cancer


2020-03-01


2021-07-25


2021-08-25


8

Study Overview

EUS-RFA for Unresectable Pancreatic Cancer

The clinical application of intraoperative or percutaneous radiofrequency ablation (RFA) for pancreatic ductal adenocarcinoma (PDAC) is limited due to higher mortality and incidence of adverse events. The aim of this study was to evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC. Patients with unresectable PDAC who underwent EUS-RFA were included from September 2013 to June 2016. Pre- and post-procedural clinical data was retrospective collected.

evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC.

  • Pancreatic Ductal Adenocarcinoma
  • PROCEDURE: EUS-RFA
  • 2013-01-112

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-03-10  

N/A  

2021-08-27  

2020-03-15  

N/A  

2021-08-30  

2020-03-17  

N/A  

2021-08  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: EUS-RFA

Patients were placed in the lateral position under deep sedation with supplementary oxygen and electrocardiograph monitoring. The target tumor was identified by EUS, then the biopsy needle stylet was removed and replace with the RFA probe. RF energy was a

PROCEDURE: EUS-RFA

  • Use EUS-RFA to treat unresectable pancreatic cancer
Primary Outcome MeasuresMeasure DescriptionTime Frame
Tumor sizeTumor size2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Serum levels of CA19-9Serum levels of CA19-9 before and after surgery2 years
survival rateincluding Overall survival2 years
Adverse eventsAdverse events2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
20 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:

  • age 20 to 80 years old. ② unresectable PDAC based on review of abdominal cross-sectional imaging (CT or MRI) and cytology/ histology results. ③Intolerance to chemotherapy due to side effects or patient's comorbidities.

  • Exclusion Criteria:

  • Pregnancy or breast-feeding;②ECOG performance status 3 or 4;③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Xiaofeng Zhang, M.S, First People's Hospital of Hangzhou

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available