Solid Pancreatic MassesNCT04607720
Clinical Research on a Novel Deep-learning Based System in Pancreatic Mass Diagnosis
A study testing artificial-EUS-FNA and AI-EUS-FNA in people with Solid Pancreatic Masses, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
In this study, a single-center, prospective, self-control, and blind design was adopted. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Solid Pancreatic Masses
- What is being tested?
- artificial-EUS-FNA and AI-EUS-FNA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 30 Jun 2022
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old, <90 years old 2.The patient is confirmed to be a solid pancreatic mass in imaging examinations (MRI, CT or ultrasound), and CH-EUS is required for auxiliary diagnosis 3. Agree to participate in this study and sign the CH-EUS informed consent form
Who cannot join
- Subjects who meet any of the following criteria cannot be selected for this trial:
- First. The patient's physical condition does not meet the requirements of conventional ultrasound endoscopic puncture:
- Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
- Blood coagulation dysfunction (platelet count <50×1012, international standardized ratio> 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week
- Anesthesia assessment failed
- Had acute pancreatitis within 2 weeks
Show all 15Show fewer
- Pregnancy or breastfeeding
- Known history of allergy to sulfur hexafluoride or other components
- Recent acute coronary syndrome or clinically unstable ischemic heart attack
- Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.
- Second. Disagree to participate in this study
- Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:
- Pancreatic disease has undergone surgery or chemotherapy beforehand
- The patient was diagnosed with pancreatic cystic disease or duodenal stenosis
- Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
Wang Xiaoyan, MD, +8613974889301, wxy20011@163.com
About this study
Official title: Clinical Research on a Noval Deep-learning Based System in Benign and Malignant Pancreatic Masses Diagnosing Under Harmonic Contrast-enhanced Endoscopic Ultrasound
In this study, a single-center, prospective, self-control, and blind design was adopted.
Read the detailed description
It is planned to enroll 100 patients with solid pancreatic masses who are to be diagnosed with contrast-enhanced harmonic endoscopy ultrasonography (CH-EUS) follow by EUS-guided fine-needle aspiration (EUS-FNA). First, all patients will be diagnosed both by the AI-assisted diagnosis system and the endoscopists under CH-EUS; Second, to compare the EUS-FNA under the guidance of the AI-assisted ultrasound diagnosis system and the EUS-FNA under manual identification, patients were randomly assigned to undergo EUS-FNA with or without the guidance of AI-assisted diagnosis system for the first two passes.
- Conditions
- Solid Pancreatic Masses
- Being tested
- artificial-EUS-FNA, AI-EUS-FNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial-EUS-FNAProcedure or surgery
The ultrasound endoscopists manually determined the region of interest (ROI) according to CH-EUS, and punctured 2 needles in the tumor area with a 22G needle, and each needle moved 15-20 times back and forth in the lesion. After puncture, insert the needle core, rinse the needle with 0.1ml sterile saline, and further apply air flushing to ensure that each tissue is sent to the slide.
AI-EUS-FNAProcedure or surgery
In the AI-assisted diagnosis system, the assisted targeting EUS-FNA unit is applied, and the ultrasound endoscopist selects the region of interest (ROI) according to the thermogram to perform targeted EUS-FNA puncture(2 needles in the same way).
| Study group | Role | What they receive |
|---|---|---|
| the artificial-EUS-FNA group | Experimental | the first two passes were made without the AI-assisted diagnosis system guidance during EUS-FNA, and then two passes were made under guidance from the AI-assisted diagnosis system Receives: Procedure: artificial-EUS-FNA; Procedure: AI-EUS-FNA |
| the AI-EUS-FNA group | Experimental | the first two passes were made with the AI-assisted diagnosis system guidance and then another two manual passes without the AI-assisted diagnosis system guidance. Receives: Procedure: artificial-EUS-FNA; Procedure: AI-EUS-FNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
Measured: 1 year
sensitivity
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
Measured: 1 year
specificity
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
Measured: 1 year
positive predictive value
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
Measured: 1 year
negative predictive value
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
Measured: 1 year
the diagnosis rate of first needle aspiration
compared the diagnosis rate of AI-EUS-FNA and artificial-EUS-FNA first needle aspiration for benign and malignant pancreatic masses
Measured: 1 year
Secondary outcomes (1)
core tissue length
To evaluate the specimen quality through core tissue length of AI-EUS-FNA and artificial-EUS-FNA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start1 Jan 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
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 Solid Pancreatic MassesStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Tian, MD, Principal investigator, The Third Xiangya Hospital of Central South UniversityAnliu Tang, MD, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607720
- Sponsor's protocol ID
- 2020-CH-EUS-AI
- Status last verified
- Oct 2020
- First submitted
- 18 Oct 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tang A, Tian L, Gao K, Liu R, Hu S, Liu J, Xu J, Fu T, Zhang Z, Wang W, Zeng L, Qu W, Dai Y, Hou R, Tang S, Wang X. Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) MASTER: A novel deep learning-based system in pancreatic mass diagnosis. Cancer Med. 2023 Apr;12(7):7962-7973. doi: 10.1002/cam4.5578. Epub 2023 Jan 6.
PubMed 36606571
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on a Noval Deep-learning Based System in Benign and Malignant Pancreatic Masses Diagnosing Under Harmonic Contrast-enhanced Endoscopic Ultrasound
- ClinicalTrials.gov ID
- NCT04607720
- Acronym / sponsor ID
- 2020-CH-EUS-AI
- Conditions
- Solid Pancreatic Masses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 29 Oct 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.
In this study, a single-center, prospective, self-control, and blind design was adopted.
Detailed description
It is planned to enroll 100 patients with solid pancreatic masses who are to be diagnosed with contrast-enhanced harmonic endoscopy ultrasonography (CH-EUS) follow by EUS-guided fine-needle aspiration (EUS-FNA). First, all patients will be diagnosed both by the AI-assisted diagnosis system and the endoscopists under CH-EUS; Second, to compare the EUS-FNA under the guidance of the AI-assisted ultrasound diagnosis system and the EUS-FNA under manual identification, patients were randomly assigned to undergo EUS-FNA with or without the guidance of AI-assisted diagnosis system for the first two passes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the artificial-EUS-FNA group | Experimental | Procedure: artificial-EUS-FNA, Procedure: AI-EUS-FNAthe first two passes were made without the AI-assisted diagnosis system guidance during EUS-FNA, and then two passes were made under guidance from the AI-assisted diagnosis system |
| the AI-EUS-FNA group | Experimental | Procedure: artificial-EUS-FNA, Procedure: AI-EUS-FNAthe first two passes were made with the AI-assisted diagnosis system guidance and then another two manual passes without the AI-assisted diagnosis system guidance. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥18 years old, <90 years old 2.The patient is confirmed to be a solid pancreatic mass in imaging examinations (MRI, CT or ultrasound), and CH-EUS is required for auxiliary diagnosis 3. Agree to participate in this study and sign the CH-EUS informed consent form
Key exclusion criteria (15 listed)
- Subjects who meet any of the following criteria cannot be selected for this trial:
- First. The patient's physical condition does not meet the requirements of conventional ultrasound endoscopic puncture:
- Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
- Blood coagulation dysfunction (platelet count <50×1012, international standardized ratio> 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week
- Anesthesia assessment failed
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 |
|---|---|---|
| artificial-EUS-FNAThe ultrasound endoscopists manually determined the region of interest (ROI) according to CH-EUS, and punctured 2 needles in the tumor area with a 22G needle, and each needle moved 15-20 times back and forth in the lesion. After puncture, insert the needle core, rinse the needle with 0.1ml sterile saline, and further apply air flushing to ensure that each tissue is sent to the slide. | Procedure or surgery | the AI-EUS-FNA group, the artificial-EUS-FNA group |
| AI-EUS-FNAIn the AI-assisted diagnosis system, the assisted targeting EUS-FNA unit is applied, and the ultrasound endoscopist selects the region of interest (ROI) according to the thermogram to perform targeted EUS-FNA puncture(2 needles in the same way). | Procedure or surgery | the AI-EUS-FNA group, the artificial-EUS-FNA group |
Primary outcome
accuracy
Time frame: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
sensitivity
Time frame: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
specificity
Time frame: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
positive predictive value
Time frame: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
negative predictive value
Time frame: 1 year
compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses
the diagnosis rate of first needle aspiration
Time frame: 1 year
compared the diagnosis rate of AI-EUS-FNA and artificial-EUS-FNA first needle aspiration for benign and malignant pancreatic masses
1 secondary outcome
core tissue length
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Derived from this study: PubMed 36606571Tang A, Tian L, Gao K, Liu R, Hu S, Liu J, Xu J, Fu T, Zhang Z, Wang W, Zeng L, Qu W, Dai Y, Hou R, Tang S, Wang X. Contrast-enhanced harmonic endoscopic ultrasound (CH-EUS) MASTER: A novel deep learning-based system in pancreatic mass diagnosis. Cancer Med. 2023 Apr;12(7):7962-7973. doi: 10.1002/cam4.5578. Epub 2023 Jan 6.
- Individual participant dataSharing planned: No
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Pancreatic Masses
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.
Li Tian, MD principal investigator
The Third Xiangya Hospital of Central South University
Anliu Tang, MD principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificial-EUS-FNA and AI-EUS-FNA in people with Solid Pancreatic Masses, run by The Third Xiangya Hospital of Central South University 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 15 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: status not confirmed, as of the sponsor's last update on 29 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Xiao, MD (+8613974889301, wxy20011@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy (time frame: 1 year). The study lists 6 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 NCT04607720, 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 29 Oct 2020.