Clinical trial · Observational
Evaluation of the Interobserver Agreement on the Resectability Status of Patients With a Pancreatic Cancer
Interobserver Variability In The Assessment Of Vascular Invasion In Pancreatic Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Assessment of interobserver variability to define vascular invasion and resectability status on CT scans
- timeFrame
- Eight months
- description
- 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).
Secondary outcomes (1)
- measure
- Identification of disagreement causes and proposal of a new classification system
- timeFrame
- One year
- description
- In case of significant low agreement (K \< 0,5), causes of disagreement will be assessed and a new classification of vascular involvement will be proposed to reduce the disagreement. The new classification will be validated on the remaining 69 CT scans
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Evidence of metastatic disease * Inadequate quality CT scan (non-respecting the NCCN recommendations) * Absence of cytology/histology confirmation * Refusal to participate in the study
References
Publications (0)
Data not yet available