The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery

February 25, 2024 updated by: Zhijun Bao, Fudan University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huadong Hospital Affiliated to Fudan University
        • Contact:
        • Contact:

Participation Criteria

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients who accept the scan of pCLE
Device: probe confocal laser endomicroscopy
probe confocal laser endomicroscopy will be used to identify the tumor behavior

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnostic efficacy
Time Frame: up to 30 postoperative days
Sensitivity(Se), Specificity(Sp), Accuracy, positive predictive value (PPV), Negative predictive value (NPV),
up to 30 postoperative days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of R0 resection
Time Frame: up to 30 postoperative days
Percentage of R0 margins in pancreatic cancer surgery by using PCLE
up to 30 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

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 Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

October 17, 2023

First Submitted That Met QC Criteria

February 25, 2024

First Posted (Estimated)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

February 25, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Huadong Hospital of FudanU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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