Update januari 2020: 32 patiënten geïncludeerd
Intra-operative ULTRAsound to determine the vascular involvement and resectability of locally advanced and (borderline) resectable PANCreatic cancer
Background: Determination of tumor extension and resectability of pancreatic cancer, especially after neoadjuvant chemotherapy, is troublesome on preoperative imaging. The assessment of vascular involvement is particularly important since these are the most affected resection margins, in addition a vascular resection can be performed to aim for a radical resection. The value of intra-operative ultrasound (IOUS) in adequate assessment of tumor extension, vascular involvement and resectability with subsequent IOUS-guided resection has scarcely been studied.
Objective: To assess the added value and diagnostic accuracy of IOUS in predicting resectability of pancreatic cancer.
Study design: Non-randomized prospective multicenter cohort study.
Study population: Patients with (suspected) pancreatic adenocarcinoma planned for curative-intended resection with vascular involvement (excl. splenic vessels) on pre-operative imaging, treated with(out) neoadjuvant chemotherapy, aged 18 years or older.
Primary outcome: Correlation preoperative imaging – IOUS in the assessment of resectability.
Definition of primary outcome:
– Resectable: absence of arterial contactand ≤ 180° venous contact
– Borderline resectable: ≤ 180° arterial contact and reconstructible venous contact
– Locally Advanced: > 180° arterial contact and unreconstructible venous contact
– Change in surgical plan before and after IOUS’
– Correlation between IOUS and pathological examination
– Resection margin status
Sample size: Eighty-five patients are required to achieve 81% power to detect an odds ratio of 7.000 using a two-sided McNemar power test with a significance level of 0.05. The odds ratio is equivalent to a difference between two paired proportions of 0.15. To allow for a valid sub-group analysis, the number of included patients treated with(out) neoadjuvant chemotherapy will be closely monitored.
Ethics & Privacy guarantee: Study related documents will be reviewed by the ethics committee of the Leiden University Medical Center. This study will be conducted in accordance with national and local laws. All data will be collected on a Case Report Form and stored in Castor EDC. Patient specific data through which the identity of the patient can be traced back will not be stored. All patient-hospital-numbers will be coded. The key between the patient-hospital-number and the study number will be enrolled in a log book per study center.
Publication and authorship: The results will be submitted to a peer reviewed journal regardless of the outcomes. Shared first authorship is granted to the study coordinators. Shared senior authorship is granted to the principal investigators. Co-authors will follow the ICMJE recommendations and will be listed alphabetically. Per participating center, one authorship is available for at least three included patients and two authorships in case of ≥six included patients. All other contributors will be listed as collaborators.