EUS-RFA for Unresectable Pancreatic Cancer

NCT ID: NCT04310111

Last Updated: 2021-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-08-25

Brief Summary

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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.

Detailed Description

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

Conditions

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Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

EUS-RFA

Intervention Type PROCEDURE

Use EUS-RFA to treat unresectable pancreatic cancer

Interventions

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EUS-RFA

Use EUS-RFA to treat unresectable pancreatic cancer

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First People's Hospital of Hangzhou

OTHER

Sponsor Role lead

Responsible Party

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Jianfeng Yang

Associate director of gastroenterology department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaofeng Zhang, M.S

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

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Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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2013-01-112

Identifier Type: -

Identifier Source: org_study_id

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