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EUS-RFA for Unresectable Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04310111
Recruitment Status : Recruiting
First Posted : March 17, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Jianfeng Yang, First People's Hospital of Hangzhou

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pancreatic Ductal Adenocarcinoma Procedure: EUS-RFA Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Endoscopic Ultrasonography-guided Radiofrequency Ablation in Treatment of Locally Advanced, Unresectable Pancreatic Cancer
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/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 applied for 90-120 seconds at 5 Watts. Wait 1 minute before repositioning the Habib™ EUS RFA needle and repeat procedure as many times as needed to ensure complete ablation of the tumor. EUS-guided celiac plexus neurolysis (EUS-CPN) was performed on patients with intractable upper abdominal pain.
Procedure: EUS-RFA
Use EUS-RFA to treat unresectable pancreatic cancer




Primary Outcome Measures :
  1. Tumor size [ Time Frame: 2 years ]
    Tumor size


Secondary Outcome Measures :
  1. Serum levels of CA19-9 [ Time Frame: 2 years ]
    Serum levels of CA19-9 before and after surgery

  2. survival rate [ Time Frame: 2 years ]
    including Overall survival

  3. Adverse events [ Time Frame: 2 years ]
    Adverse events



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT04310111


Contacts
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Contact: Jianfeng Yang, M.D +86-0571-56006999 yjf-1976@163.com

Locations
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China, Zhejiang
Hangzhou First People's Hospital Recruiting
Hangzhou, Zhejiang, China, 31006
Contact: Jianfeng Yang, M.D    +86-0571-56006999    yjf-1976@163.com   
Sponsors and Collaborators
First People's Hospital of Hangzhou
Investigators
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Principal Investigator: Xiaofeng Zhang, M.S First People's Hospital of Hangzhou

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Responsible Party: Jianfeng Yang, Associate director of gastroenterology department, First People's Hospital of Hangzhou
ClinicalTrials.gov Identifier: NCT04310111    
Other Study ID Numbers: 2013-01-112
First Posted: March 17, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jianfeng Yang, First People's Hospital of Hangzhou:
Pancreatic ductal adenocarcinoma
Unresectable pancreatic cancer
Radiofrequency ablation
Endoscopic ultrasound
Additional relevant MeSH terms:
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Adenocarcinoma
Pancreatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases