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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04977596
Other study ID # yurisheng
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2012
Est. completion date June 25, 2019

Study information

Verified date March 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date June 25, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: 1. Diagnosis by pathology and detailed pathological information 2. Enhanced CT examination or biopsy were performed within 2 months before surgery 3. There was no preoperative radiotherapy or chemotherapy Exclusion Criteria: 1. No Ki-67 index 2. CT value cannot be measured by ROI because of pancreatic atrophy and other reasons 3. No enhanced images or missing images

Study Design


Intervention

Other:
No intervention
Retrospective study without intervention

Locations

Country Name City State
China Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (3)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University The First Affiliated Hospital of the Fourth Military Medical University, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumor size Maximum surface size of the lesion (cm) preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Tumor location Locations of the pancreas: head, neck, body and tail preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Number of lesions Number of lesions preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Margin well-defined or ill-defined preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary tumor texture solid;solid and cystic;complex cystic preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Pancreatic tail contraction yes or no preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Complicated pancreatitis yes or no preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Pancreatic duct/bile duct dilatation yes or no preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Extrapancreatic tissue invasion yes or no preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Hepatic metastasis yes or no preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary Lymphatic metastasis yes or no preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary CT value of pancreas plain scan CT value of pancreas plain scan preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary CT value of lesion plain scan CT value of lesion plain scan preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary CT value of pancreas artery phase CT value of pancreas artery phase preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary CT value of lesion artery phase CT value of lesion artery phase preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary CT value of pancreas portal phase CT value of pancreas portal phase preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Primary CT value of lesion portal phase CT value of lesion portal phase preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
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