Pancreatic CancerNCT03267966
Margin Status After Pancreaticoduodenectomy for Cancer
A study testing Leeds Pathology Protocol (LEEPP) in people with Pancreatic Cancer and Cholangiocarcinoma, run by Campus Bio-Medico University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Cholangiocarcinoma, Ampullary Cancer
- What is being tested?
- Leeds Pathology Protocol (LEEPP)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pancreaticoduodenectomy for periampullary cancer
Who cannot join
- 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).
About this study
Official title: Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial
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.
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Ampullary Cancer
- Being tested
- Leeds Pathology Protocol (LEEPP)
- Keywords
- periampullary cancer, margin status, R1 resection, clearance margin
- Medical subject headings
- Pancreatic Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leeds Pathology Protocol (LEEPP)Diagnostic test
LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Leeds Pathology Protocol (LEEPP) Receives: Diagnostic Test: Leeds Pathology Protocol (LEEPP) |
| Group B | No intervention | "Conventional" method of pathological evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
R1 resection rate
To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance
Measured: 1 month
Secondary outcomes (2)
pathological data
To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups
Measured: 1 month
oncological results
To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Collaborators
- Humanitas Hospital, Italy, Azienda Ospedaliero, Universitaria Pisana, Medical University of Silesia
- Responsible party
- Principal investigator, Gennaro Nappo, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03267966
- Sponsor's protocol ID
- NI 01/13
- Status last verified
- Feb 2020
- First submitted
- 11 Aug 2017
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT03267966
- Acronym / sponsor ID
- NI 01/13
- Conditions
- Pancreatic Cancer, Cholangiocarcinoma, Ampullary Cancer
- Keywords
- periampullary cancer, margin status, R1 resection, clearance margin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Collaborators
- Humanitas Hospital, Italy, Azienda Ospedaliero, Universitaria Pisana, Medical University of Silesia
- Study start
- Mar 2013 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Diagnostic Test: Leeds Pathology Protocol (LEEPP)Leeds Pathology Protocol (LEEPP) |
| Group B | No intervention | –"Conventional" method of pathological evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pancreaticoduodenectomy for periampullary cancer
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leeds Pathology Protocol (LEEPP)LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance | Diagnostic test | Group A |
Primary outcome
R1 resection rate
Time frame: 1 month
To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance
2 secondary outcomes
pathological data
Time frame: 1 month
oncological results
Time frame: 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Leeds Pathology Protocol (LEEPP) in people with Pancreatic Cancer and Cholangiocarcinoma, run by Campus Bio-Medico University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R1 resection rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.