Pancreas NeoplasmNLRNCT04724551
The Neutrophil-to-Lymphocyte Ratio to Exclude Pancreatic Fistula
An observational study of Pancreas Neoplasm, run by Institut Paoli-Calmettes.
Trial summary
There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Neoplasm
- What is being tested?
- pancreatoduodenectomy (PD)
- Type of treatment
- Surgery or procedure
- How many people
- 648 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2012to 28 Feb 2021
- Phase
- Observational
- 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
Study population: 3 cohorts, which were as follows: the set of 451 patients was randomly sampled following a ratio 2:1 into a training (n=301) and a validation (n=150) cohort to respectively determine and validate the accuracy, best timing, and cut-off for the surrogate markers, then validated in an external cohort (n=197).
Who may be able to join
- Patients who underwent pancreatoduodenectomy
Who cannot join
- Total pancreatectomy
- Enucleation
About this study
Official title: The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy
There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.
Read the detailed description
From January 1, 2012 to December 31, 2020, consecutive patients underwent PD performed at Institut Paoli-Calmettes for various pathologies. Data were entered prospectively into a clinical database (NCT02871336).
The cohort was split into 3 groups:
- a training cohort ;
- an internal validation cohort (Paoli Calmettes institute);
- an external validation cohort (Rennes Pontchaillou Hospital).
- Conditions
- Pancreas Neoplasm
- Being tested
- pancreatoduodenectomy (PD)
- Keywords
- Pancreatic fistula, Neutrophil-to-Lymphocyte Ratio, Pancreatoduodenectomy
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pancreatoduodenectomy (PD)Procedure or surgery
A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of clinically relevant pancreatic fistula
Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition
Measured: at hospital discharge assessed up to 30 days
Secondary outcomes (1)
Biological markers
Identification of biological markers to exclude clinically relevant postoperative pancreatic fistula
Measured: Postoperative day one and three
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Jun 2012
- Primary completion31 Dec 2020
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas NeoplasmStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 648 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Turrini, PD, Principal investigator, Institut Paoli-Calmettes- (IPC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04724551
- Sponsor's protocol ID
- NLR-IPC 2020-058
- Acronym
- NLR
- Status last verified
- Jan 2021
- First submitted
- 19 Jan 2021
- Last updated
- 28 May 2021
- 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 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Neutrophil-to-Lymphocyte Ratio at Post-operative Day 3: a Simple Tool to Exclude Clinically Relevant Postoperative Pancreatic Fistula After Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT04724551
- Acronym / sponsor ID
- NLR / NLR-IPC 2020-058
- Conditions
- Pancreas Neoplasm
- Keywords
- Pancreatic fistula, Neutrophil-to-Lymphocyte Ratio, Pancreatoduodenectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 648 participants (actual)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 1 Jun 2012 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 26 Jan 2021 (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.
There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.
Detailed description
From January 1, 2012 to December 31, 2020, consecutive patients underwent PD performed at Institut Paoli-Calmettes for various pathologies. Data were entered prospectively into a clinical database (NCT02871336).
The cohort was split into 3 groups:
- a training cohort ;
- an internal validation cohort (Paoli Calmettes institute);
- an external validation cohort (Rennes Pontchaillou Hospital).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 3 cohorts, which were as follows: the set of 451 patients was randomly sampled following a ratio 2:1 into a training (n=301) and a validation (n=150) cohort to respectively determine and validate the accuracy, best timing, and cut-off for the surrogate markers, then validated in an external cohort (n=197).
Key inclusion criteria (1 listed)
- Patients who underwent pancreatoduodenectomy
Key exclusion criteria (2 listed)
- Total pancreatectomy
- Enucleation
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 |
|---|---|---|
| pancreatoduodenectomy (PD)A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture. | Procedure or surgery | – |
Primary outcome
Incidence of clinically relevant pancreatic fistula
Time frame: at hospital discharge assessed up to 30 days
Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition
1 secondary outcome
Biological markers
Time frame: Postoperative day one and three
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 28 May 2021.
- 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.
Olivier Turrini, PD principal investigator
Institut Paoli-Calmettes- (IPC)
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Neoplasm, run by Institut Paoli-Calmettes.
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 2 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 28 May 2021. 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?
Incidence of clinically relevant pancreatic fistula (time frame: at hospital discharge assessed up to 30 days). 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 28 May 2021.