Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer
1 other identifier
observational
200
1 country
1
Brief Summary
The 18F-FDG-PET scan is currently being used for cancer diagnosis, staging, identifying hidden metastasis, and assessment of treatment responses in clinical oncology. Although there are important studies suggesting potential associations between PET-based parameters and oncologic outcomes, the calculation and official documentation of individual PET-based parameters might not be routine in clinical practice because these processes usually require time- and labor-consuming processes for the radiologists. In this study, the investigators prospectively determined clinical 18F-FDG-PET type according to degree of FDG-uptake in pancreatic cancer and compare oncologic outcomes between the types.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 7, 2014
CompletedFirst Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
March 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 17, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 17, 2018
CompletedJanuary 11, 2019
January 1, 2019
3.9 years
February 20, 2017
January 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical PET type assessed by surgeons from preoperatively preformed PET imaging
Three surgeons will review the preoperative PET imaging and each will determine the clinical PET type as either K-type or Non-K type. Inter-surgeon agreement of clinical PET type will be determined. Clinicopathologic characteristics between K-type and Non-K type will also be analyzed.
1 week after surgery
Secondary Outcomes (1)
Number of patients with recurrence of cancer or mortality from cancer following operation
3 years
Study Arms (2)
K-type
FDG uptake in pancreatic cancer is similar to that of kidney
non K-type
FDG uptake in pancreatic cancer is lower than that of kidney
Interventions
PET-CT will be done before operation and that is routine treatment procedure for pancreatic cancer.
Eligibility Criteria
Tertiary Referral Hospital
You may qualify if:
- Candidate for radical pancreatectomy due to pancreatic cancer without neoadjuvant treatment
- Age between 20 years old and 80 years old
- General performance status greater than 70
- Results of peroperative PET-CT available
You may not qualify if:
- Unresectable, locally advance and metastatic pancreatic cancer
- Patients not wanting operation
- ASA score of greater than 3
- History of chronic alcoholism ot drug abuse
- Lack of patient compliance
- Patients not agreeing to enroll in the study.
- Patients unable to understand and sign the study agreement.
- History of neoadjuvant treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine
Seoul, 03722, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2017
First Posted
March 10, 2017
Study Start
October 7, 2014
Primary Completion
September 17, 2018
Study Completion
September 17, 2018
Last Updated
January 11, 2019
Record last verified: 2019-01