Margin Status After Pancreaticoduodenectomy for Cancer

Campus Bio-Medico University of Rome

Status: Completed

Conditions: Cholangiocarcinoma; Ampullary Cancer; Pancreatic Cancer

Treatments: Diagnostic Test: Leeds Pathology Protocol (LEEPP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03267966

NI 01/13

Details and patient eligibility

About

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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Group A

Experimental group

Description:

Leeds Pathology Protocol (LEEPP)

Treatment:

Diagnostic Test: Leeds Pathology Protocol (LEEPP)

Group B

No Intervention group

Description:

"Conventional" method of pathological evaluation