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Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer

NCT03673423 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 138

Last updated 2018-12-13

No results posted yet for this study

Summary

Assess the degree of vascular involvement is crucial in the diagnostic and therapeutic work-up of pancreatic cancer. NCCN resectability classification is used to stratify patients (in resectable, borderline resectable and non resectable) and is based on contrast-enhanced CT scan images. Unfortunately evaluation of imaging tests may rely on some degree of subjective interpretation by observers implying a fundamental variation in patient's treatments and an irreproducibility of different center study results.

This is a multicenter diagnostic study on interobserver agreement on the resectability of pancreatic cancer based upon NCCN criteria.

The primary aim of the study will be the assessment of interobserver variability to define vascular invasion and resectability status on CT scans (according to the last version of the NCCN Classification).

One hundred and thirty eight consecutive patients, able to produce an informed consent, from 18 years of age, with a non-metastatic pancreatic adenocarcinoma assessed by a contrast-enhanced high-quality CT scan will be enrolled.

69 CT scan studies provided by the centers involved (High volume for pancreatic surgery) will be randomly selected from a pool of 138 of the patients that meet the inclusion criteria. Each study will be independently reviewed by a senior radiologist and a senior surgeon of each center, blinded to patient's clinical history and CT scan report, using NCCN definition of respectability status. A CFR will be filled during the review and send to the study coordinator. The data will be than centrally analyzed to asses interobserver agreement The enrolment phase will last 6 months and the whole study will last 8 months.

Conditions

  • Pancreatic Adenocarcinoma

Sponsors & Collaborators

  • Ospedale San Raffaele

    lead OTHER

Principal Investigators

  • Gianpaolo Balzano, MD · Ospedale San Raffaele

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-05
Primary Completion
2019-03-05
Completion
2019-05-05

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03673423 on ClinicalTrials.gov