The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery

NCT06289803 | Recruiting DMC

• 1 other identifier: Huadong Hospital of FudanU
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pancreatic Cancer; Diagnosis; Pancreatoduodenectomy; Distal Pancreatectomy

Keywords

pancreatic cancer; confocal laser endomicroscopy; resection margin; diagnosis; radical resection

Outcome Measures

Primary Outcomes (1)

• diagnostic efficacy

  Sensitivity(Se), Specificity(Sp), Accuracy, positive predictive value (PPV), Negative predictive value (NPV),

  up to 30 postoperative days

Secondary Outcomes (1)

• Rate of R0 resection

  up to 30 postoperative days

Study Arms (1)

patients who accept the scan of pCLE

EXPERIMENTAL

Device: probe confocal laser endomicroscopy

Interventions

probe confocal laser endomicroscopy DEVICE

probe confocal laser endomicroscopy will be used to identify the tumor behavior

patients who accept the scan of pCLE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Huadong Hospital affiliated to Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Disease; Margins of Excision

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Central Study Contacts

Chongyi Jiang, PhD

CONTACT

+86-18101802916; jiangzhongyi9@126.com

Chunjing Li, M.S

CONTACT

14790068967; Lcj1479006@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Model Details: Patients diagnosed with pancreatic tumours will undergo surgical resection, and PCLE will be used for identifying the behaviour of tumours (benign or malignant neoplasms) and predicting the status of resection margin.

Study Record Dates

• First Submitted: October 17, 2023
• First Posted: March 4, 2024
• Study Start: September 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: June 30, 2025
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

CN (1)