Clinical trial NCT04977596: Related Studies of Imaging Features and Prognosis Between Pancreatic Neuroendocrine Tumors and Pancreatic Cancer
Official title: Grade 3 Pancreatic Neuroendocrine Tumors on MDCT: Establishing a Diagnostic Model and Comparing Survival Against Pancreatic Ductal Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neuroendocrine Tumor of Pancreas
Carcinoma, Pancreatic
CT
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Zhejiang University
name: The First Affiliated Hospital of the Fourth Military Medical University
First posted: 2021-07-27
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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, patients with G3 PNET who underwent MDCT at the First Affiliated Hospital of Zhejiang University School of Medicine (n = 4) and the Military Medical University of Air Force (The Fourth Military Medical University) (n = 4) between January 2013 and October 2018, and consecutive 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.

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Tumor size
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Tumor location
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Number of lesions
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Margin
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: tumor texture
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Pancreatic tail contraction
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Complicated pancreatitis
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Pancreatic duct/bile duct dilatation
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Extrapancreatic tissue invasion
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Hepatic metastasis
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: Lymphatic metastasis
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: CT value of pancreas plain scan
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: CT value of lesion plain scan
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: CT value of pancreas artery phase
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: CT value of lesion artery phase
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: CT value of pancreas portal phase
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
measure: CT value of lesion portal phase
timeFrame: preoperative contrast-enhanced CT performed within 2 months before surgery or biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Risheng Yu
role: PRINCIPAL_INVESTIGATOR
References: