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| Name | Class |
|---|---|
| Humanitas Hospital, Italy | OTHER |
| Azienda Ospedaliero, Universitaria Pisana | OTHER |
| Medical University of Silesia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Leeds Pathology Protocol (LEEPP) |
|
| Group B | No Intervention | "Conventional" method of pathological evaluation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leeds Pathology Protocol (LEEPP) | Diagnostic Test | LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance |
|
| Measure | Description | Time Frame |
|---|---|---|
| R1 resection rate | To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| pathological data | To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups | 1 month |
| oncological results | To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| 60 months |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |