Using laser technology to improve pancreatic tumor surgery
The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery
This study is testing a new laser technology during pancreatic tumor surgery to see if it can help doctors quickly tell if a tumor is cancerous or not, which could lead to better treatment decisions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06289803 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Probe Confocal Laser Endomicroscopy (PCLE) during surgery for pancreatic tumors. Patients diagnosed with pancreatic neoplasms will undergo radical resection, and PCLE will be utilized to determine whether the tumor is malignant or benign in real-time. The study consists of two phases: the first phase aims to develop diagnostic imaging criteria based on postoperative pathology, while the second phase will apply these criteria for rapid intraoperative diagnosis and assessment of resection margins. The goal is to enhance surgical decision-making and reduce unnecessary resections.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with pancreatic tumors who are scheduled for pancreatoduodenectomy or distal pancreatectomy and can tolerate surgery.
Not a fit: Patients with other systemic malignancies or those who have already received a definitive pathological diagnosis prior to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses during surgery, potentially reducing unnecessary surgical procedures for benign tumors.
How similar studies have performed: While PCLE has shown promise in other studies for diagnosing tumors, this specific application in pancreatic surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. patients are diagnosed with pancreatic neoplasms based on preoperative radiographic findings and auxiliary examination results, and they will undergo pancreatoduodenectomy or distal pancreatectomy. 2. Patients who have no serious abnormalities of blood system, heart and lung function and immune deficiency and can tolerate surgery. 3. Patients who are not allergic to fluorescein sodium will be included. Exclusion Criteria: 1. Patients accompanied by other systemic malignancies. 2. Central nervous system disease, mental disease, unstable angina pectoris, congestive heart failure, serious arrhythmia and other uncontrollable serious diseases, unable to tolerate surgery. 3. Patients who have had definitive pathologic diagnosis before surgery will be excluded. 4. 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.
Where this trial is running
Shanghai, Shanghai
- Huadong Hospital affiliated to Fudan University — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Chongyi Jiang, PhD
- Email: jiangzhongyi9@126.com
- Phone: +86-18101802916
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.