Pancreatic Adenocarcinoma Non-resectableNCT03772756
EUS-RFA for Unresectable Pancreatic Ductal Adenocarcinoma
A study testing Endoscopic ultrasound guided radiofrequency ablation and chemoradiotherapy in people with Pancreatic Adenocarcinoma Non-resectable, run by First People's Hospital of Hangzhou at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Adenocarcinoma Non-resectable
- What is being tested?
- Endoscopic ultrasound guided radiofrequency ablation and chemoradiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 2 sitesChina
- Study dates
- 20 Dec 2018to 16 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Jianfeng Yang
Hangzhou, Zhejiang, 310006
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 31006
About this study
Official title: Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial
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.
Read the detailed description
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 .
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Being tested
- Endoscopic ultrasound guided radiofrequency ablation, chemoradiotherapy
- Keywords
- pancreatic adenocarcinoma, radiofrequency ablation, Endoscopic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound guided radiofrequency ablationProcedure or surgery
Also called EUS-RFA
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.
chemoradiotherapyRadiation
Receive chemoradiotherapy
| Study group | Role | What they receive |
|---|---|---|
| EUS-RFA group | Experimental | Patients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy Receives: Procedure: Endoscopic ultrasound guided radiofrequency ablation; Radiation: chemoradiotherapy |
| control group | Active comparator | the control group will receive chemoradiotherapy only Receives: Radiation: chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tumour size as measured on EUS and or CT
The tumor size was compared before and after 60 days EUS-RFA
Measured: 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
Measured: 60 days
Secondary outcomes (2)
Overall survival at 6 months
Survival rate 6 months after EUS-RFA
Measured: 6 months
Overall survival at 12 months
Survival rate 12 months after EUS-RFA
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start20 Dec 2018
- Primary completion16 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Adenocarcinoma Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianfeng Yang, First People's Hospital of Hangzhou
- Investigators
- Xiaofeng Zhang, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772756
- Sponsor's protocol ID
- 2018-139-01
- Status last verified
- Aug 2021
- First submitted
- 9 Dec 2018
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23049547
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound Guided Radiofrequency Ablation (EUS-RFA) for Unresectable Pancreatic Adenocarcinoma - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03772756
- Acronym / sponsor ID
- 2018-139-01
- Conditions
- Pancreatic Adenocarcinoma Non-resectable
- Keywords
- pancreatic adenocarcinoma, radiofrequency ablation, Endoscopic ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 16 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-RFA group | Experimental | Procedure: Endoscopic ultrasound guided radiofrequency ablation, Radiation: chemoradiotherapyPatients in EUS-RFA group will undergo endoscopic ultrasound guided radiofrequency ablation(EUS-RFA ) and chemoradiotherapy |
| control group | Active comparator | Radiation: chemoradiotherapythe control group will receive chemoradiotherapy only |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic ultrasound guided radiofrequency ablationAlso: EUS-RFAEndoscopic 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. | Procedure or surgery | EUS-RFA group |
| chemoradiotherapyReceive chemoradiotherapy | Radiation | EUS-RFA group, control group |
Primary outcome
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
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
2 secondary outcomes
Overall survival at 6 months
Time frame: 6 months
Overall survival at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 23049547Gaidhane 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaofeng Zhang principal investigator
First People's Hospital of Hangzhou
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound guided radiofrequency ablation and chemoradiotherapy in people with Pancreatic Adenocarcinoma Non-resectable, run by First People's Hospital of Hangzhou at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in tumour size as measured on EUS and or CT (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03772756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.