Margin Status After Pancreaticoduodenectomy for Cancer

Not Applicable

Completed

• Conditions: Pancreatic Cancer; Ampullary Cancer; Cholangiocarcinoma
• Interventions: Diagnostic Test: Leeds Pathology Protocol (LEEPP)

• Registration Number: NCT03267966
• Lead Sponsor: Campus Bio-Medico University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Primary Completion: 2015-06
• Study First Submitted: 2017-08-11
• Study First Submitted QC: 2017-08-29
• Study First Posted: 2017-08-31
• Study Completion: 2019-06
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-05
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Leeds Pathology Protocol (LEEPP)	Leeds Pathology Protocol (LEEPP)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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