NCT03772756

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
9 days until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

2.7 years

First QC Date

December 9, 2018

Last Update Submit

August 27, 2021

Conditions

Pancreatic Adenocarcinoma Non-resectable

Keywords

pancreatic adenocarcinomaradiofrequency ablationEndoscopic ultrasound

Outcome Measures

Primary Outcomes (2)

  • Change in tumour size as measured on EUS and or CT

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

    60 days

  • Change in serum levels of Ca 19-9

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

    60 days

Secondary Outcomes (2)

  • Overall survival at 6 months

    6 months

  • Overall survival at 12 months

    12 months

Study Arms (2)

EUS-RFA group

EXPERIMENTAL

Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy

Procedure: Endoscopic ultrasound guided radiofrequency ablationRadiation: chemoradiotherapy

control group

ACTIVE COMPARATOR

the control group will receive chemoradiotherapy only

Radiation: chemoradiotherapy

Interventions

Endoscopic ultrasound guided radiofrequency ablationPROCEDURE

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.

Also known as: EUS-RFA
EUS-RFA group
chemoradiotherapyRADIATION

Receive chemoradiotherapy

EUS-RFA groupcontrol group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jianfeng Yang

Hangzhou, Zhejiang, 310006, China

Location

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 31006, China

Location

Related Publications (1)

  • Gaidhane M, Smith I, Ellen K, Gatesman J, Habib N, Foley P, Moskaluk C, Kahaleh M. Endoscopic Ultrasound-Guided Radiofrequency Ablation (EUS-RFA) of the Pancreas in a Porcine Model. Gastroenterol Res Pract. 2012;2012:431451. doi: 10.1155/2012/431451. Epub 2012 Sep 20.

    PMID: 23049547BACKGROUND

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyRadiotherapy

Study Officials

  • Xiaofeng Zhang

    First People's Hospital of Hangzhou

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate director of gastroenterology department

Study Record Dates

First Submitted

December 9, 2018

First Posted

December 11, 2018

Study Start

December 20, 2018

Primary Completion

August 16, 2021

Study Completion

August 16, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Locations

CN(2)