Pancreatic FistulaNCT04361682
Preoperative Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Pancreatic Fistula After Pancreaticoduodenectomy
An observational study of Pancreatic Fistula and Pancreas Cancer, run by Campus Bio-Medico University.
Trial summary
Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pancreatic Fistula, Pancreas Cancer, Inflammatory Response
- What is being tested?
- Surgical Drain Management
- Type of treatment
- Surgery or procedure
- How many people
- 227 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2005to 1 Apr 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to the inclusion criteria, 227 patients were eligible for the study. The median age of all the series was 69 years (IQR= 60.25-74). Male patients were 131 (57.7%), the median BMI was 24.06 Kg/m2 (IQR= 22.15-27.59). Biochemical leak, grade B and grade C PF have been detected in 67/227 (29.5%), 21/227 (9.25%) and 22/227 (9.7%) of the cases, respectively.
Who may be able to join
- Patients underwent pancreaticoduodenectomy (PD) for periampullary neoplasms
- Patients underwent PD with pancreaticojejunostomy reconstruction.
- Patient with data of blood count in first postoperative day
Who cannot join
- None of the above criteria
About this study
Official title: Preoperative Systemic Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Grade C Pancreatic Fistula After Pancreaticoduodenectomy: a Retrospective Single Center Experience
Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).
Read the detailed description
Data from a prospective collected database of 317 consecutive PDs performed at the University Campus Bio-Medico di Roma during the years 2005-2019, have been retrospectively analyzed. Local Ethical Committee approved the study.
Patients undergoing PD for periampullary neoplasms were included in the study. All patients underwent to PD with pancreaticojejunostomy reconstruction. Two surgical drains were always placed at the end of the surgery.
Data regarding PIBs, as full blood count including white blood cell (WBC) count, lymphocytes, neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (NLR), derived neutrophil-to-lymphocyte ratio (d-NLR), platelet-to-lymphocyte ratio (PLR) and POD1-d.a. levels were collected and Positive Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop PF combining PIBs and drains amylase values.
- Conditions
- Pancreatic Fistula, Pancreas Cancer, Inflammatory Response
- Being tested
- Surgical Drain Management
- Keywords
- Pancreatic Fistula, Pancreatic anastomoses, Surgical Drain Management, Inflammatory Biomarkers
- Medical subject headings
- Pancreatic Fistula, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Drain ManagementProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of PIBs and drains amylase values for Pancreatic Fistula (PF)
Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop Pancreatic Fistula (PF) combining PIBs and Postoperative Day 1 Drain Amylase Value
Measured: pre-intervention/ Day 1 after the intervention/up to discharge"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 Jan 2005
- Primary completion31 Dec 2019
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic FistulaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damiano Caputo, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04361682
- Sponsor's protocol ID
- 27/19 OSS ComEt CBM
- Status last verified
- Apr 2020
- First submitted
- 21 Apr 2020
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Systemic Inflammatory Biomarkers and Postoperative Day 1 Drain Amylase Value Predict Grade C Pancreatic Fistula After Pancreaticoduodenectomy: a Retrospective Single Center Experience
- ClinicalTrials.gov ID
- NCT04361682
- Acronym / sponsor ID
- 27/19 OSS ComEt CBM
- Conditions
- Pancreatic Fistula, Pancreas Cancer, Inflammatory Response
- Keywords
- Pancreatic Fistula, Pancreatic anastomoses, Surgical Drain Management, Inflammatory Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 1 Jan 2005 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Apr 2020 (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.
Particularly, pancreatic fistula is the most common and serious complication after pancreaticoduodenectomy (PD) and is reported in up to 40% of cases. The aim of this retrospective single-center study was to investigate the utility of the combination of preoperative inflammation biomarkers (PIBs) with postoperative day 1 drains amylase (POD1-d.a.) levels in predicting grade C Pancreatic Fistula (PF).
Detailed description
Data from a prospective collected database of 317 consecutive PDs performed at the University Campus Bio-Medico di Roma during the years 2005-2019, have been retrospectively analyzed. Local Ethical Committee approved the study.
Patients undergoing PD for periampullary neoplasms were included in the study. All patients underwent to PD with pancreaticojejunostomy reconstruction. Two surgical drains were always placed at the end of the surgery.
Data regarding PIBs, as full blood count including white blood cell (WBC) count, lymphocytes, neutrophils and platelets counts, neutrophil-to-lymphocyte ratio (NLR), derived neutrophil-to-lymphocyte ratio (d-NLR), platelet-to-lymphocyte ratio (PLR) and POD1-d.a. levels were collected and Positive Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop PF combining PIBs and drains amylase values.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the inclusion criteria, 227 patients were eligible for the study. The median age of all the series was 69 years (IQR= 60.25-74). Male patients were 131 (57.7%), the median BMI was 24.06 Kg/m2 (IQR= 22.15-27.59). Biochemical leak, grade B and grade C PF have been detected in 67/227 (29.5%), 21/227 (9.25%) and 22/227 (9.7%) of the cases, respectively.
Key inclusion criteria (3 listed)
- Patients underwent pancreaticoduodenectomy (PD) for periampullary neoplasms
- Patients underwent PD with pancreaticojejunostomy reconstruction.
- Patient with data of blood count in first postoperative day
Key exclusion criteria (1 listed)
- None of the above criteria
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 |
|---|---|---|
| Surgical Drain Management | Procedure or surgery | – |
Primary outcome
Predictive value of PIBs and drains amylase values for Pancreatic Fistula (PF)
Time frame: pre-intervention/ Day 1 after the intervention/up to discharge"
Predictive Values (PPV) and Negative Predictive Values (NPV) were computed to investigate the probability to develop Pancreatic Fistula (PF) combining PIBs and Postoperative Day 1 Drain Amylase Value
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 24 Apr 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?
An observational study of Pancreatic Fistula and Pancreas Cancer, 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 3 inclusion and 1 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 24 Apr 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?
Predictive value of PIBs and drains amylase values for Pancreatic Fistula (PF) (time frame: pre-intervention/ Day 1 after the intervention/up to discharge"). 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 24 Apr 2020.