Ampullary Cancer, Cholangiocarcinoma, Pancreatic Cancer
Conditions
Keywords
periampullary cancer, margin status, R1 resection, clearance margin
Brief summary
This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other conventional pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.
Interventions
DIAGNOSTIC_TESTLeeds Pathology Protocol (LEEPP)
LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance
Sponsors
Humanitas Hospital, Italy
Azienda Ospedaliero, Universitaria Pisana
Medical University of Silesia
Campus Bio-Medico University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* pancreaticoduodenectomy for periampullary cancer
Exclusion criteria
* diagnosis of neuroendocrine neoplasm; * previous pancreatic surgery; * frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection); * presence of macroscopic residual tumor (R2 resection).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| R1 resection rate | 1 month | To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pathological data | 1 month | To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups |
| oncological results | 60 months | To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups |
Outcome results
None listed