EUS-RFA for Unresectable Pancreatic Cancer

NCT04310111 | Completed DMC

• 1 other identifier: 2013-01-112
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Ductal Adenocarcinoma

Keywords

Pancreatic ductal adenocarcinoma; Unresectable pancreatic cancer; Radiofrequency ablation; Endoscopic ultrasound

Outcome Measures

Primary Outcomes (1)

• Tumor size

  Tumor size

  2 years

Secondary Outcomes (3)

• Serum levels of CA19-9

  2 years

• survival rate

  2 years

• Adverse events

  2 years

Study Arms (1)

EUS-RFA

EXPERIMENTAL

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

Interventions

EUS-RFA PROCEDURE

Use EUS-RFA to treat unresectable pancreatic cancer

EUS-RFA

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• First People's Hospital of Hangzhou: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

Study Officials

• Xiaofeng Zhang, M.S

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate director of gastroenterology department

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 17, 2020
• Study Start: March 1, 2020
• Primary Completion: July 25, 2021
• Study Completion: August 25, 2021
• Last Updated: August 30, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)