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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077334
• Other study ID #: 4-2014-0702
• Status: Completed
• Start date: October 7, 2014
• Est. completion date: September 17, 2018

Study information

• Verified date: January 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• PET-CT
PET-CT will be done before operation and that is routine treatment procedure for pancreatic cancer.

Locations

Country	Name	City	State
Korea, Republic of	Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of patients with recurrence of cancer or mortality from cancer following operation		3 years