Brief Title
Margin Status After Pancreaticoduodenectomy for Cancer
Official Title
Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial
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.
Study Type
Interventional
Primary Outcome
R1 resection rate
Secondary Outcome
pathological data
Condition
Pancreatic Cancer
Intervention
Leeds Pathology Protocol (LEEPP)
Study Arms / Comparison Groups
Group A
Description: Leeds Pathology Protocol (LEEPP)
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
168
Start Date
March 2013
Completion Date
June 2019
Primary Completion Date
June 2015
Eligibility Criteria
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).
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
, ,
Administrative Informations
NCT ID
NCT03267966
Organization ID
NI 01/13
Responsible Party
Principal Investigator
Study Sponsor
Campus Bio-Medico University
Collaborators
Humanitas Hospital, Italy
Study Sponsor
, ,
Verification Date
February 2020