Related Studies of Imaging Features and Prognosis Between Pancreatic Neuroendocrine Tumors and Pancreatic Cancer

Grade 3 Pancreatic Neuroendocrine Tumors on MDCT: Establishing a Diagnostic Model and Comparing Survival Against Pancreatic Ductal Adenocarcinoma

  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

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

78

Contacts and Locations

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

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital of Zhejiang University School of Medicine

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
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 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

Cohorts and Interventions

Group / Cohort
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, 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
Retrospective study without 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.
Retrospective study without intervention

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Risheng Yu, Second Affiliated Hospital of Zhejiang University School of Medicine

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)

January 1, 2012

Primary Completion (ACTUAL)

January 1, 2019

Study Completion (ACTUAL)

June 25, 2019

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

July 25, 2021

First Posted (ACTUAL)

July 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 27, 2021

Last Update Submitted That Met QC Criteria

July 25, 2021

Last Verified

March 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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