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

NCT03673423 | Unknown

• 1 other identifier: OBTCPAN
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Resectability Status; NCCN criteria

Outcome Measures

Primary Outcomes (1)

• Assessment of interobserver variability to define vascular invasion and resectability status on CT scans

  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).

  Eight months

Secondary Outcomes (1)

• Identification of disagreement causes and proposal of a new classification system

  One year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

138 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.

You may qualify if:

• Age \> 18 years
• Non-metastatic pancreatic adenocarcinoma
• Availability of contrast enhanced CT scan with adequate quality. Section thickness must be \<3 mm, according to NCCN recommendations
• Pathological confirmation of pancreatic adenocarcinoma by cytology/histology is not required at the time of enrolment, but it is needed before including the CT scan in the pool of exams to be evaluated.
• Signed informed consent

You may not qualify if:

• Evidence of metastatic disease
• Inadequate quality CT scan (non-respecting the NCCN recommendations)
• Absence of cytology/histology confirmation
• Refusal to participate in the study

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Study Officials

• Gianpaolo Balzano, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Giannone, MD

CONTACT

+3903401036108; giannone.fabio@hsr.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 17, 2018
• Study Start: September 5, 2018
• Primary Completion: March 5, 2019
• Study Completion: May 5, 2019
• Last Updated: December 13, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)