2023-09-01
2025-01-31
2025-06-30
200
NCT06289803
Fudan University
Fudan University
INTERVENTIONAL
The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery
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.
Accurately identifying benign and malignant pancreatic tumor is a challenge for surgeons. Although pathological reports are the golden standard for determining the behaviour of pancreatic tumor, it's too late for patients with benign tumor because excessive resection has been performed. Unnecessary resection will cause great harm for those patients. Freezing microtomy during surgery is a method to distinguish the essence of the tumor in surgery, but it's still time-consuming and inaccurate. Recently, lots of studies reported that Probe Confocal Laser Endomicroscopy (PCLE) is potentially effective tool for determining the nature of pancreatic tumor with high sensitivity and specificity. However, there are no imaging criteria regarding PCLE for the diagnosis of pancreatic cancer, and it's underused in intraoperative scenes of pancreatic surgery for quickly recognizing malignant pancreatic tumor. The aim of the present study is to summarize the special structures of image collecting by PCLE and evaluate its practical value. If PLCE is proven to be as diagnostic efficiency as pathology in this study, patients who diagnosed with pancreatic benign tumor by PCLE will opt for local excision rather than pancreaticoduodenectomy or distal pancreatectomy. What's more, if patients are diagnosed with pancreatic cancer by PCLE, example pancreatic adenocarcinoma, they will undergo radical resection (the Whipple procedure or distal pancreatectomy). In addition, PCLE will be used for predicted the status of resection margin. If positive margin status are detected by scanning the wound of tumor, surgeons will expand the resection.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates | Results Reporting Dates | Study Record Updates |
---|---|---|
2023-10-17 | N/A | 2024-02-25 |
2024-02-25 | N/A | 2024-03-04 |
2024-03-04 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: patients who accept the scan of pCLE | DEVICE: probe confocal laser endomicroscopy
|
Primary Outcome Measures | Measure Description | Time Frame |
---|---|---|
diagnostic efficacy | Sensitivity(Se), Specificity(Sp), Accuracy, positive predictive value (PPV), Negative predictive value (NPV), | up to 30 postoperative days |
Secondary Outcome Measures | Measure Description | Time Frame |
---|---|---|
Rate of R0 resection | Percentage of R0 margins in pancreatic cancer surgery by using PCLE | up to 30 postoperative days |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact Name: Chongyi Jiang, PhD Phone Number: +86-18101802916 Email: jiangzhongyi9@126.com |
Study Contact Backup Name: Chunjing Li, M.S Phone Number: 14790068967 Email: Lcj1479006@163.com |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available