UnknownNot Applicable

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

China100 participantsStarted 2020-01-01

Plain-language summary

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

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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
. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

accuracy

Timeframe: 1 year

sensitivity

Timeframe: 1 year

specificity

Timeframe: 1 year

positive predictive value

Timeframe: 1 year

negative predictive value

Timeframe: 1 year

the diagnosis rate of first needle aspiration

Timeframe: 1 year

Trial details

NCT IDNCT04607720

SponsorThe Third Xiangya Hospital of Central South University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-31

Contact for this trial

Wang Xiao, MD

+8613974889301 wxy20011@163.com

View on ClinicalTrials.gov More Solid Pancreatic Masses trials

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. 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
. 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.