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Completed

NCT Number: NCT03077334

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

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.

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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Hepatobiliary and Pancreatic Surgery, Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET-CT

Device

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

Primary outcomes

  1. Clinical PET type assessed by surgeons from preoperatively preformed PET imaging

    Time frame: 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 outcomes

  1. Number of patients with recurrence of cancer or mortality from cancer following operation

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Mar 10, 2017
Registry last updated
Jan 11, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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