Oncologic Outcomes Based on Clinical Pattern of Preoperative PET-CT in Resected Pancreatic Cancer

Completed

• Conditions: Pancreatic Cancer
• Interventions: Device: PET-CT

• Registration Number: NCT03077334
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-07
• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-10
• Primary Completion: 2018-09-17
• Study Completion: 2018-09-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
K-type	PET-CT	FDG uptake in pancreatic cancer is similar to that of kidney
non K-type	PET-CT	FDG uptake in pancreatic cancer is lower than that of kidney

Primary Outcome Measures

Name	Time	Method
Clinical PET type assessed by surgeons from preoperatively preformed PET imaging	1 week after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Number of patients with recurrence of cancer or mortality from cancer following operation	3 years

Trial Locations

Locations (1)

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine; 🇰🇷 Seoul, Korea, Republic of