Back to resultsMargin Status After Pancreaticoduodenectomy for Cancer
Primary Purpose
Pancreatic Cancer, Cholangiocarcinoma, Ampullary Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Leeds Pathology Protocol (LEEPP)
Sponsored by
About this trial
This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring periampullary cancer, margin status, R1 resection, clearance margin
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Group A
Group B
Arm Description
Leeds Pathology Protocol (LEEPP)
"Conventional" method of pathological evaluation
Outcomes
Primary Outcome Measures
R1 resection rate
To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance
Secondary Outcome Measures
pathological data
To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups
oncological results
To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups
Full Information
NCT ID
NCT03267966
First Posted
August 11, 2017
Last Updated
February 5, 2020
Sponsor
Campus Bio-Medico University
Collaborators
Humanitas Hospital, Italy, Azienda Ospedaliero, Universitaria Pisana, Medical University of Silesia
1. Study Identification
Unique Protocol Identification Number
NCT03267966
Brief Title
Margin Status After Pancreaticoduodenectomy for Cancer
Official Title
Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
Collaborators
Humanitas Hospital, Italy, Azienda Ospedaliero, Universitaria Pisana, Medical University of Silesia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Cholangiocarcinoma, Ampullary Cancer
Keywords
periampullary cancer, margin status, R1 resection, clearance margin
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
Leeds Pathology Protocol (LEEPP)
Arm Title
Group B
Arm Type
No Intervention
Arm Description
"Conventional" method of pathological evaluation
Intervention Type
Diagnostic Test
Intervention Name(s)
Leeds Pathology Protocol (LEEPP)
Intervention Description
LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance
Primary Outcome Measure Information:
Title
R1 resection rate
Description
To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance
Time Frame
1 month
Secondary Outcome Measure Information:
Title
pathological data
Description
To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups
Time Frame
1 month
Title
oncological results
Description
To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups
Time Frame
60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Margin Status After Pancreaticoduodenectomy for Cancer
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