Multicentric Pancreas

Project objectives

Consistent literature data report that neoplastic infiltration of the surgical exeresis margins (Microscopic Residual Tumor, R1) after Duodeno-Cephalo-Pancreasectomy (DCP) for cancer is a highly significant prognostic factor. It has also been verified that the rate of R1 after DCP for cancer varies between 0 and 83% of cases. This wide variability effectively prevents verifying the true prognostic impact of the neoplastic infiltration of the surgically resected after PCD for cancer. The incidence of R1 rate has always been considered as an indicator of the quality of surgical treatment: with the lowest R1 rates indicating the highest quality level of the exeresis. However, the role played by the pathologist has recently been emphasized in this context. This is also following the evidence that a standardized method for the histological evaluation of surgically resected after DCP developed in European pathological centers has led to a significant increase in the rate of R1 regardless of the quality of the exeresis itself. This "standardized" method is characterized by the following peculiarities:

1. Multi-color marking of the different resection margins;
2. Introduction of the concept of Circumferential Resection Margin (MRC) and its specific spatial definition;
3. Macroscopic section technique of the surgical resected called "axial slicing" consisting in the section of the pancreatic head passing through the plane perpendicular to the major axis of the duodenum;
4. Definition of a minimum distance of 1 mm between the tumor and each margin in order to define the margin itself as non-infiltrated (this is in contrast to the practice which also establishes a margin with a distance equal to zero mm from the tumor as non-infiltrated).

The preliminary statistical analysis performed involves the enrollment and randomization in the two study arms of 180 surgically resected patients after DCP for periampullary neoplasia. The resected patients allocated to the first arm will be managed in accordance with the so-called "standardised" method described above while those belonging to the second arm will be managed with a method that can be generally defined as non-standardised. In particular, this will consist in the application of the method already used by each of the centers involved in the study.

Objectives of the study

Primary: difference in incidence of the R1 rate in the two arms

Secondary: differences between the two arms of the following parameters:

1. Incidence of lymph node metastases
2. Incidence by pathological staging in terms of each of the T factors
3. Evaluation of specific biomolecular markers associated with pancreatic cancer
4. Overall survival
5. Disease-free survival
6. Man-hours used
7. Economic costs

Start and end date

Project Manager

Coordinating institution of the project

Other Institutions involved

• Medical University of Silesia, Katowice, Poland
• Humanitas Clinical Institute, Milan, Italy
• Pisana University Hospital, Pisa, Italy

Funding source(s).