The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery (NCT06289803) | Clinical Trial Compass
UnknownNot Applicable
The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery
China200 participantsStarted 2023-09-01
Plain-language summary
Aim of the study: To evaluate the value of Probe Confocal Laser Endomicroscopy (PCLE) in surgery for pancreatic tumor.
Methods:
Patients who are diagnosed with pancreatic tumor based on preoperative radiographic findings and will undergo radical resection are included in this clinical study. PCLE will be used in surgery to identify tumor is malignant or not, and surgeons will decide procedures of surgery based on outcomes of PCLE. In this present study, clinical trials will be divided into two phases. In the first phase, based on the definitive postoperative pathologic diagnosis, characteristic imaging structures that were collected by PCLE will be identified and primary diagnostic imaging criteria for pancreatic cancer would be developed. In the second phase, this criterion will be used for rapid intraoperative diagnosis of pancreatic cancer and predicting status of resection margin. In addition, accuracy of PCLE will be verified based on postoperative pathologic reports.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. patients are diagnosed with pancreatic neoplasms based on preoperative radiographic findings and auxiliary examination results, and they will undergo pancreatoduodenectomy or distal pancreatectomy.
. Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery.
. Patients who are not allergic to fluorescein sodium will be included.
Exclusion criteria
. Patients accompanied by other systemic malignancies.
. Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery.
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.
. Patients who have had definitive pathologic diagnosis before surgery will be excluded.
. Any condition that may impair the safety of patients or the integrity of research data, including serious medical risk factors, medical conditions, and laboratory abnormalities.