EUS-RFA for Unresectable Pancreatic Cancer

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Efficacy and Safety of Endoscopic Ultrasonography-guided Radiofrequency Ablation in Treatment of Locally Advanced, Unresectable Pancreatic Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310111
• Other study ID #: 2013-01-112
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: August 25, 2021

Study information

• Verified date: August 2021
• Source: First People's Hospital of Hangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: August 25, 2021
• Est. primary completion date: July 25, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Ductal Adenocarcinoma
• Pancreatic Neoplasms

Intervention

Procedure:
• EUS-RFA
Use EUS-RFA to treat unresectable pancreatic cancer

Locations

Country	Name	City	State
China	Hangzhou First People's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Hangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor size	Tumor size	2 years
Secondary	Serum levels of CA19-9	Serum levels of CA19-9 before and after surgery	2 years
Secondary	survival rate	including Overall survival	2 years
Secondary	Adverse events	Adverse events	2 years