2013-03
2015-06
2019-06
168
NCT03267966
Campus Bio-Medico University
Campus Bio-Medico University
INTERVENTIONAL
Margin Status After Pancreaticoduodenectomy for Cancer
This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other Ȭonventional" 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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2017-08-11 | N/A | 2020-02-05 |
2017-08-29 | N/A | 2020-02-06 |
2017-08-31 | N/A | 2020-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Diagnostic
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Group A Leeds Pathology Protocol (LEEPP) | DIAGNOSTIC_TEST: Leeds Pathology Protocol (LEEPP)
|
| NO_INTERVENTION: Group B "Conventional" method of pathological evaluation |
| Primary Outcome Measures | 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 |
| Secondary Outcome Measures | 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 | 60 months |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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