Clinical Research on a Novel Deep-learning Based System in Pancreatic Mass Diagnosis

Solid Pancreatic Masses Clinical Trial

Official title:

Clinical Research on a Noval Deep-learning Based System in Benign and Malignant Pancreatic Masses Diagnosing Under Harmonic Contrast-enhanced Endoscopic Ultrasound

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04607720
• Other study ID #: 2020-CH-EUS-AI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2020
• Source: The Third Xiangya Hospital of Central South University
• Contact: Wang Xiao, MD
• Phone: +8613974889301
• Email: wxy20011[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, a single-center, prospective, self-control, and blind design was adopted.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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:

1. Poor physical condition, including hemoglobin =8.0g/dl, severe cardiopulmonary insufficiency, etc.

2. Blood coagulation dysfunction (platelet count <50×1012, international standardized ratio> 1.5) or taking oral anticoagulants such as aspirin or warfarin within a week

3. Anesthesia assessment failed

4. Had acute pancreatitis within 2 weeks

5. Pregnancy or breastfeeding

6. Known history of allergy to sulfur hexafluoride or other components

7. Recent acute coronary syndrome or clinically unstable ischemic heart attack

8. 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:

1. Pancreatic disease has undergone surgery or chemotherapy beforehand

2. The patient was diagnosed with pancreatic cystic disease or duodenal stenosis

3. Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up

Related Conditions & MeSH terms

• Solid Pancreatic Masses

Intervention

Procedure:
• artificial-EUS-FNA
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-FNA
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).

Locations

Country	Name	City	State
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	accuracy	compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses	1 year
Primary	sensitivity	compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses	1 year
Primary	specificity	compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses	1 year
Primary	positive predictive value	compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses	1 year
Primary	negative predictive value	compare the diagnostic rates of AI-CH-EUS and artificial-CH-EUS for benign and malignant pancreatic masses	1 year
Primary	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	1 year
Secondary	core tissue length	To evaluate the specimen quality through core tissue length of AI-EUS-FNA and artificial-EUS-FNA	1 year