Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:56 PM
Study NCT ID:
NCT06289803
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2023-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: