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

Central South University

Status: Unknown

Conditions: Solid Pancreatic Masses

Treatments: Procedure: AI-EUS-FNA; Procedure: artificial-EUS-FNA

Study type: Interventional

Funder types: Other

Identifiers

NCT04607720

2020-CH-EUS-AI

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

the artificial-EUS-FNA group

Experimental group

Description:

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

Treatment:

Procedure: AI-EUS-FNA

Procedure: artificial-EUS-FNA

the AI-EUS-FNA group

Experimental group

Description:

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.

Treatment:

Procedure: AI-EUS-FNA

Procedure: artificial-EUS-FNA