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Completed

NCT Number: NCT03772756

EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma

the study evaluate the efficacy and safety of EUS-RFA using Habib EUS-RFA catheter with a prospective randomised trial in patients with inoperable PDAC.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hangzhou First People's Hospital, Hangzhou, Zhejiang, China

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About this study

The five year survival for pancreatic ductal adenocarcinoma (PDAC) is less than 5% in spite of the advances in management of cancers in the last few decades. Endobiliary application of radiofrequency ablation (RFA) has been developed in our unit and used in patients with unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. Various techniques of EUS-guided tumour ablation have been described, including RF ablation, photodynamic therapy, laser ablation, and ethanol injection. Endoscopic ultrasound guided RFA (EUS-RFA) of the pancreatic head using Habib EUS-RFA catheter through a 19-gauge needle was well tolerated in 5 Yucatan pigs and with minimum amount of pancreatitis .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients in the age group 20 to 80 years
  • A cytological or histological diagnosis of inoperable PDAC based on multidisciplinary review of cross sectional imaging and cytology or histology results.
  • Patients who have been deemed unfit for surgical resection of the PDAC subjects who are fit for surgical resection but have declined surgery will also be considered for the study
  • PDAC patients presenting with jaundice to be considered after a successful biliary drainage
  • Patients ought to be fit enough to be considered for the study (ECOG performance status 0, 1 or 2)
  • Patients capable of giving informed consent

Exclusion criteria

  • Inability to give informed consent
  • Pregnancy or breast feeding
  • ECOG performance status 3 or 4
  • Life expectancy less than 3 months
  • Patients with distant metastases or malignant ascites

Treatment and study plan

Endoscopic ultrasound guided radiofrequency ablation

Procedure

Endoscopic ultrasound guided radiofrequency ablation (EUS-RFA) will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.

Other names: EUS-RFA

Chemoradiotherapy

Radiation

Receive chemoradiotherapy

Primary outcomes

  1. Change in tumour size as measured on EUS and or CT

    Time frame: 60 days

    The tumor size was compared before and after 60 days EUS-RFA

  2. Change in serum levels of Ca 19-9

    Time frame: 60 days

    Serum levels of Ca 19-9 was compared before and after 60 days EUS-RFA

Secondary outcomes

  1. Overall survival at 6 months

    Time frame: 6 months

    Survival rate 6 months after EUS-RFA

  2. Overall survival at 12 months

    Time frame: 12 months

    Survival rate 12 months after EUS-RFA

Sponsors and collaborators

Lead sponsor

First People's Hospital of Hangzhou

Other

Registry information

Official study title

Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2018
Registry last updated
Aug 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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