Clinical trial NCT04607720: Clinical Research on a Novel Deep-learning Based System in Pancreatic Mass Diagnosis
Official title: Clinical Research on a Noval Deep-learning Based System in Benign and Malignant Pancreatic Masses Diagnosing Under Harmonic Contrast-enhanced Endoscopic Ultrasound
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Solid Pancreatic Masses
Lead sponsor: The Third Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: accuracy
timeFrame: 1 year
measure: sensitivity
timeFrame: 1 year
measure: specificity
timeFrame: 1 year
measure: positive predictive value
timeFrame: 1 year
measure: negative predictive value
timeFrame: 1 year
measure: the diagnosis rate of first needle aspiration
timeFrame: 1 year
Secondary outcomes:
measure: core tissue length
timeFrame: 1 year
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: The Third Xiangya Hospital of Central South University
name: Li Tian, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Third Xiangya Hospital of Central South University
name: Anliu Tang, MD
role: PRINCIPAL_INVESTIGATOR
References: