Pancreatic Ductal AdenocarcinomaNCT04310111
EUS-RFA for Unresectable Pancreatic Cancer
A study testing EUS-RFA in people with Pancreatic Ductal Adenocarcinoma, run by First People's Hospital of Hangzhou at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Pancreatic Ductal Adenocarcinoma
- What is being tested?
- EUS-RFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2020to 25 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy or breast-feeding；②ECOG performance status 3 or 4；③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Endoscopic Ultrasonography-guided Radiofrequency Ablation in Treatment of Locally Advanced, Unresectable Pancreatic Cancer
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.
Read the detailed description
evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC.
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Being tested
- EUS-RFA
- Keywords
- Pancreatic ductal adenocarcinoma, Unresectable pancreatic cancer, Radiofrequency ablation, Endoscopic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS-RFAProcedure or surgery
Use EUS-RFA to treat unresectable pancreatic cancer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: EUS-RFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size
Tumor size
Measured: 2 years
Secondary outcomes (3)
Serum levels of CA19-9
Serum levels of CA19-9 before and after surgery
Measured: 2 years
survival rate
including Overall survival
Measured: 2 years
Adverse events
Adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start1 Mar 2020
- Primary completion25 Jul 2021
- Study completion25 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Ductal AdenocarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 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, M.S, Principal investigator, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310111
- Sponsor's protocol ID
- 2013-01-112
- Status last verified
- Aug 2021
- First submitted
- 10 Mar 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
- Efficacy and Safety of Endoscopic Ultrasonography-guided Radiofrequency Ablation in Treatment of Locally Advanced, Unresectable Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04310111
- Acronym / sponsor ID
- 2013-01-112
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Keywords
- Pancreatic ductal adenocarcinoma, Unresectable pancreatic cancer, Radiofrequency ablation, Endoscopic ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 17 Mar 2020 (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 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
evaluate the efficacy and safety of endoscopic ultrasonography-guided RFA (EUS-RFA) for locally advanced, unresectable PDAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EUS-RFA | Experimental | Procedure: EUS-RFAPatients 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Pregnancy or breast-feeding；②ECOG performance status 3 or 4；③Patients with distant metastases or malignant ascites, life expectancy less than 3 months.
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 |
|---|---|---|
| EUS-RFAUse EUS-RFA to treat unresectable pancreatic cancer | Procedure or surgery | EUS-RFA |
Primary outcome
Tumor size
Time frame: 2 years
Tumor size
3 secondary outcomes
Serum levels of CA19-9
Time frame: 2 years
survival rate
Time frame: 2 years
Adverse events
Time frame: 2 years
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.
- Individual participant dataSharing planned: No
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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, M.S principal investigator
First People's Hospital of Hangzhou
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EUS-RFA in people with Pancreatic Ductal Adenocarcinoma, run by First People's Hospital of Hangzhou at 1 site 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 1 inclusion and 1 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 1 site 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?
Tumor size (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.