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2012-01-01
2019-01-01
2019-06-25
78
NCT04977596
Second Affiliated Hospital, School of Medicine, Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
OBSERVATIONAL
Related Studies of Imaging Features and Prognosis Between Pancreatic Neuroendocrine Tumors and Pancreatic Cancer
1. Imaging findings (including CT and MRI images) of both well-differentiated G3 PNET and poorly differentiated PNET were studied; 2. The CT imaging findings of G3 stage PNET and pancreatic cancer were compared to establish a Logistic regression diagnostic model, and the survival analysis of the two was compared. 3. Cox regression was used to study the risk factors for survival prognosis of well-differentiated and poorly differentiated PNET based on CT image features
According to the latest WHO Classification of Neuroendocrine Neoplasms (NET) in 2019, pancreatic neuroendocrine neoplasms (PNET) are divided into well-differentiated and poorly differentiated PNETs.The former is divided into G1, G2, and well differentiated G3.There are few studies on the survival outcomes of these two differentiated PNET types.The G3 imaging manifestations of the two types of differentiation have not been studied yet, and G3 PNET is often clinically misdiagnosed as pancreatic cancer, so it is necessary to differentiate the imaging manifestations and survival time of the two types. A total of 71 patients with PNET in our hospital from January 2012 to January 2019 and 58 patients with pancreatic cancer from February 2014 to August 2015 were retrospectively collected. Complete survival time data of all patients after telephone follow-up were obtained.Since G3 PNET is very rare, the investigators enrolled 9 patients with G3 PNET in the First Affiliated Hospital of Zhejiang University School of Medicine and 7 patients with G3 PNET in the Affiliated Hospital of Air Force Military Medical University from January 2013 to October 2018. CT images of PNET and pancreatic cancer were analyzed independently by two radiologists specializing in abdominal diagnosis, in which G3 lesions were evaluated simultaneously on MRI images and the others were evaluated only on CT images.Records clinical data and imaging characteristics: gender, age, tumor markers, tumor shape, size, tumor characteristics, edge, the expansion of the shrinking, pancreas, pancreatic pancreatitis, enhancement scan, arterial phase and portal phase lesions and the ratio of pancreatic parenchyma around, liver metastasis, peripheral vascular invasion, lymph node metastasis.
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 |
|---|---|---|
2021-07-12 | N/A | 2021-07-25 |
2021-07-25 | N/A | 2021-07-27 |
2021-07-27 | N/A | 2020-03 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Group PNETs The investigators retrospectively analyzed data for patients who underwent contrast-enhanced MDCT for the evaluation of G3 PNETs at the Second Affiliated Hospital of Zhejiang University School of Medicine (n = 12) between January 2011 and May 2019, patien | OTHER: No intervention
|
| : Group PDAC Patients with PDAC who underwent MDCT at the Second Affiliated Hospital of Zhejiang University School of Medicine (n = 58) from February 2014 to August 2015. | OTHER: No intervention
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Tumor size | Maximum surface size of the lesion (cm) | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Tumor location | Locations of the pancreas: head, neck, body and tail | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Number of lesions | Number of lesions | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Margin | well-defined or ill-defined | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| tumor texture | solid；solid and cystic；complex cystic | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Pancreatic tail contraction | yes or no | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Complicated pancreatitis | yes or no | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Pancreatic duct/bile duct dilatation | yes or no | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Extrapancreatic tissue invasion | yes or no | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Hepatic metastasis | yes or no | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Lymphatic metastasis | yes or no | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| CT value of pancreas plain scan | CT value of pancreas plain scan | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| CT value of lesion plain scan | CT value of lesion plain scan | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| CT value of pancreas artery phase | CT value of pancreas artery phase | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| CT value of lesion artery phase | CT value of lesion artery phase | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| CT value of pancreas portal phase | CT value of pancreas portal phase | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| CT value of lesion portal phase | CT value of lesion portal phase | preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
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
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