Pancreatic CancerNCT06289803
The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery
A study testing probe confocal laser endomicroscopy in people with Pancreatic Cancer and Diagnosis, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer, Diagnosis, Pancreatoduodenectomy
- What is being tested?
- probe confocal laser endomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huadong Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Chunjing Li, M.S, 14790068967, Lcj1479006@163.com
Chongyi Jiang, M.D, +8618101802916, jiangzhongyi9@126.com
About this study
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.
Read the 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.
- Being tested
- probe confocal laser endomicroscopy
- Keywords
- pancreatic cancer, confocal laser endomicroscopy, resection margin, diagnosis, radical resection
- Medical subject headings
- Pancreatic Neoplasms, Disease, Margins of Excision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probe confocal laser endomicroscopyDevice
probe confocal laser endomicroscopy will be used to identify the tumor behavior
| Study group | Role | What they receive |
|---|---|---|
| patients who accept the scan of pCLE | Experimental | Not described Receives: Device: probe confocal laser endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic efficacy
Sensitivity(Se), Specificity(Sp), Accuracy, positive predictive value (PPV), Negative predictive value (NPV),
Measured: up to 30 postoperative days
Secondary outcomes (1)
Rate of R0 resection
Percentage of R0 margins in pancreatic cancer surgery by using PCLE
Measured: up to 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Sep 2023
- Primary completion31 Jan 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhijun Bao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289803
- Sponsor's protocol ID
- Huadong Hospital of FudanU
- Status last verified
- Feb 2024
- First submitted
- 17 Oct 2023
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Probe Confocal Laser Endomicroscopy in Pancreatic Tumor Surgery
- ClinicalTrials.gov ID
- NCT06289803
- Acronym / sponsor ID
- Huadong Hospital of FudanU
- Keywords
- pancreatic cancer, confocal laser endomicroscopy, resection margin, diagnosis, radical resection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| patients who accept the scan of pCLE | Experimental | Device: probe confocal laser endomicroscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probe confocal laser endomicroscopyprobe confocal laser endomicroscopy will be used to identify the tumor behavior | Device | patients who accept the scan of pCLE |
Primary outcome
diagnostic efficacy
Time frame: up to 30 postoperative days
Sensitivity(Se), Specificity(Sp), Accuracy, positive predictive value (PPV), Negative predictive value (NPV),
1 secondary outcome
Rate of R0 resection
Time frame: up to 30 postoperative days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probe confocal laser endomicroscopy in people with Pancreatic Cancer and Diagnosis, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chongyi Jiang, PhD (+86-18101802916, jiangzhongyi9@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic efficacy (time frame: up to 30 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.