NCT04977596

Brief Summary

  1. 1.Imaging findings (including CT and MRI images) of both well-differentiated G3 PNET and poorly differentiated PNET were studied;
  2. 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 27, 2021

Completed
Last Updated

July 27, 2021

Status Verified

March 1, 2020

Enrollment Period

7 years

First QC Date

July 12, 2021

Last Update Submit

July 25, 2021

Conditions

Outcome Measures

Primary Outcomes (17)

  • 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

Study Arms (2)

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

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

Interventions

Retrospective study without intervention

Group PDACGroup PNETs

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Diagnosis by pathology and detailed pathological information
  • Enhanced CT examination or biopsy were performed within 2 months before surgery
  • There was no preoperative radiotherapy or chemotherapy

You may not qualify if:

  • No Ki-67 index
  • CT value cannot be measured by ROI because of pancreatic atrophy and other reasons
  • No enhanced images or missing images

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Adenoma, Islet CellPancreatic Neoplasms

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Risheng Yu

    Second Affiliated Hospital of Zhejiang University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2021

First Posted

July 27, 2021

Study Start

January 1, 2012

Primary Completion

January 1, 2019

Study Completion

June 25, 2019

Last Updated

July 27, 2021

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations