Postoperative Acute PancreatitisISGPS-PPAPNCT05680623
Clinical and Economic Validation of the ISGPS Definition of PPAP
An observational study of Postoperative Acute Pancreatitis and Pancreaticoduodenectomy, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
This prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Acute Pancreatitis, Pancreaticoduodenectomy, Postoperative Pancreatic Fistula
- What is being tested?
- PPAP diagnosis
- Type of treatment
- Injection or infusion
- How many people
- 2,900 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2022to 12 Jan 2024
- 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: All patients scheduled to receive elective pancreaticoduodenectomy (PD - Kausch-Whipple or Longmire-Traverso) for all type of pancreatic disease (benign, malignant, or premalignant) will be enrolled.
Who may be able to join
- Scheduled for elective PD;
- Male and females ≥ 18 years;
- Upfront or after neoadjuvant therapy surgery is allowed;
- The ability of the subject to understand the character and individual consequences of the clinical trial;
- Written informed consent.
Who cannot join
- Patients undergoing emergency surgery;
- Informed consent withdrawal;
- Inability to perform the resection for any reason;
- Total or distal pancreatectomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Economic Validation of the International Study Group for Pancreatic Surgery (ISGPS) Definition of Postpancreatectomy Acute Pancreatitis (PPAP)
This prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment.
Read the detailed description
The study will be conducted at approximately 37 investigative sites in Europe, Asia, Oceania, and the United States. Only high volume centers for Pancreatic Surgery will be included in the study. All patients scheduled to receive elective pancreaticoduodenectomy (PD Kausch-Whipple or Longmire-Traverso) for all type of pancreatic disease (benign, malignant, or premalignant) will be enrolled. The study duration per subject will be up to 30 days after surgery or all the in-hospital lengths of stay. Preoperative care will follow institutional standards, according to each center involved. Surgical resection and reconstruction will be carried out according to the techniques adopted by each participating center. Both patients undergoing open and minimally invasive surgery can be considered eligible. Postoperative management will follow the institutional standards of each center. Serum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days (POD) 1 and 2.Serum C-reactive protein (CRP) will be measured according to each institutional policy and reported once assessed from POD 1 to 3. Drain fluid amylase, or lipase activity will be checked according to the Institutional standards of each involved, and the values will be retrieved whether assessed from POD 1 to five. Radiological imaging will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious for abdominal complications.The severity of complications will be assessed according to the Clavien-Dindo (CD) classification system 32 . Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery. Length of hospital stay is calculated from the day of surgery to discharge. Preoperative, intra-operative, and postoperative data will be recorded prospectively.
The estimated study duration will be 15 months. Time for data analysis must be considered negligible. Patients' follow-up will last 30 days after surgery to catch any additional morbidity even after discharge from the hospital.
- Conditions
- Postoperative Acute Pancreatitis, Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Postoperative Complications
- Being tested
- PPAP diagnosis
- Keywords
- pancreatitis, hyperamylasemia, pancreatoduodenectomy, postoperative complications, pancreatic fistula
- Medical subject headings
- Postoperative Complications, Pancreatitis, Hyperamylasemia, Pancreatic Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PPAP diagnosisDiagnostic test
Serum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days 1 and 2.
A CT with pancreas protocol iv contrast infusion will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious of abdominal complications.
| Study group | Role | What they receive |
|---|---|---|
| study population | Subgroups based on the ISGPS diagnostic criteria and the grading system of PPAP:
1. Without PPAP or POH: Patients without POH nor imaging consistent with AP.
2. POH: sustained postoperative serum hyperamylasemia neither clinically relevant nor consistent imaging
3. PPAP: requiring the fulfilment of three criteria:
* POH: sustained serum hyperamylasemia greater than the institutional upper limit of normal persisting on postoperative days 1 and 2;
* macroscopic radiologic features of AP
* clinically relevant complications. PPAP severity will be classified into grades B and C, with progressive clinical deterioration. Receives: Diagnostic Test: PPAP diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of PPAP
The incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system.
Measured: 30 postoperative days
The incidence of unplanned ICU admissions and hospital readmission in the PPAP group compared to the non-PPAP one.
Only an unplanned need for intensive care will be defined as intensive care unit (ICU) stay. Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery.
Measured: 30 postoperative days
The difference in length of hospital stay between the PPAP and the non-PPAP group
Length of hospital stay is calculated from the day of surgery to discharge.
Measured: up to hospital discharge, an average of 30 postoperative days
The difference in hospital costs among the different grades of severity according to the ISGPS grading system22: no PPAP or POH, POH, PPAP grade B, and PPAP grade C groups.
Total hospital costs will comprise the cost of the index admission and every surgery-related readmission within 30 days from the index surgery. Costs will be inflation-adjusted using the standardized national consumer price index and normalized to adjust the variability inherent to different health systems and institutions.
Measured: 30 postoperative days
Secondary outcomes (4)
Correlation between postoperative serum amylase/serum lipase activity (U/L) and radiologic feature consistent with PPAP retrieved at postoperative imaging.
Serum amylase and/or lipase activity will be systematically measured on postoperative days (POD) 1 and 2.
Radiological imaging will be performed in the postoperative course when clinically required, facing the patient's clinical worsening, and suspicious of abdominal complications.
Measured: 30 postoperative days
Incidence and descriptive analysis of radiological features consistent with PAPP at postoperative imaging retrieved at different time points.
The radiologic evaluation will include the pancreas enlargement, pancreas enhancement, pancreatic necrosis and percentage, peripancreatic collections, characteristics, and their location, haemorrhage and pseudoaneurysm, ascites, thrombosis, main pancreatic duct diameter (mm), POD imaging (days).
Measured: 30 postoperative days
Incidence and severity of postoperative morbidity.
Postoperative morbidity will be defined according to ISGPS definitions of postoperative pancreatic fistula, delayed gastric emptying, post-pancreatectomy hemorrhage, and chyle leak. Bile leakage as defined by ISGLS. Acute kidney injury will be determined according to 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The severity of complications will be assessed according to the Clavien-Dindo classification system.
Measured: 30 postoperative days
Incidence of postoperative mortality.
Mortality will be defined as postoperative death recorded out to the point of 30-days postoperatively. Beyond these time limits, the mortality, possibly related to PPAP, will be considered and discussed in each case.
Measured: 30 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Jan 2022
- Primary completion30 Sep 2023
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative Acute PancreatitisStudies 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
- Prospective
- Enrolment
- 2,900 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Heidelberg University, Catholic University of the Sacred Heart, Hospices Civils de Lyon, Lund University, Flinders Medical Centre, Amsterdam UMC, location VUmc, University of Dublin, Trinity College, Christchurch Hospital, University of Colorado, Denver, Scientific Institute San Raffaele, University of Graz, Technical University of Munich, Royal Free Hospital NHS Foundation Trust, San Gerardo Hospital, University of Liverpool, Universitätsklinikum Hamburg-Eppendorf, Massachusetts General Hospital, Kyushu University, The First Affiliated Hospital with Nanjing Medical University, Petz Aladar County Teaching Hospital, Mayo Clinic, Hospital Miguel Servet, Tata Memorial Hospital, Medical University of Vienna, Kyoto University, Graduate School of Medicine, UnitedHealth Group, Ludwig-Maximilians - University of Munich, Thomas Jefferson University, Humanitas Hospital, Italy, Indiana University Health, University of Manchester, New York University
- Responsible party
- Sponsor
- Investigators
- Giovanni Marchegiani, Principal investigator, Azienda Ospedaliera Universitaria Integrata di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680623
- Sponsor's protocol ID
- 3822CESC
- Acronym
- ISGPS-PPAP
- Status last verified
- Jan 2024
- First submitted
- 19 Oct 2022
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marchegiani G, Barreto SG, Bannone E, Sarr M, Vollmer CM, Connor S, Falconi M, Besselink MG, Salvia R, Wolfgang CL, Zyromski NJ, Yeo CJ, Adham M, Siriwardena AK, Takaori K, Hilal MA, Loos M, Probst P, Hackert T, Strobel O, Busch ORC, Lillemoe KD, Miao Y, Halloran CM, Werner J, Friess H, Izbicki JR, Bockhorn M, Vashist YK, Conlon K, Passas I, Gianotti L, Del Chiaro M, Schulick RD, Montorsi M, Olah A, Fusai GK, Serrablo A, Zerbi A, Fingerhut A, Andersson R, Padbury R, Dervenis C, Neoptolemos JP, Bassi C, Buchler MW, Shrikhande SV; International Study Group for Pancreatic Surgery. Postpancreatectomy Acute Pancreatitis (PPAP): Definition and Grading From the International Study Group for Pancreatic Surgery (ISGPS). Ann Surg. 2022 Apr 1;275(4):663-672. doi: 10.1097/SLA.0000000000005226.
PubMed 34596077Bannone E, Andrianello S, Marchegiani G, Masini G, Malleo G, Bassi C, Salvia R. Postoperative Acute Pancreatitis Following Pancreaticoduodenectomy: A Determinant of Fistula Potentially Driven by the Intraoperative Fluid Management. Ann Surg. 2018 Nov;268(5):815-822. doi: 10.1097/SLA.0000000000002900.
PubMed 30004917Loos M, Strobel O, Dietrich M, Mehrabi A, Ramouz A, Al-Saeedi M, Muller-Stich BP, Diener MK, Schneider M, Berchtold C, Feisst M, Hinz U, Mayer P, Giannakis A, Schneider D, Weigand MA, Buchler MW, Hackert T. Hyperamylasemia and acute pancreatitis after pancreatoduodenectomy: Two different entities. Surgery. 2021 Feb;169(2):369-376. doi: 10.1016/j.surg.2020.07.050. Epub 2020 Sep 25.
PubMed 32981689Chen H, Wang W, Ying X, Deng X, Peng C, Cheng D, Shen B. Predictive factors for postoperative pancreatitis after pancreaticoduodenectomy: A single-center retrospective analysis of 1465 patients. Pancreatology. 2020 Mar;20(2):211-216. doi: 10.1016/j.pan.2019.11.014. Epub 2019 Nov 27.
PubMed 31831390Partelli S, Tamburrino D, Andreasi V, Mazzocato S, Crippa S, Perretti E, Belfiori G, Marmorale C, Balzano G, Falconi M. Implications of increased serum amylase after pancreaticoduodenectomy: toward a better definition of clinically relevant postoperative acute pancreatitis. HPB (Oxford). 2020 Nov;22(11):1645-1653. doi: 10.1016/j.hpb.2020.03.010. Epub 2020 Apr 11.
PubMed 32291175
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Validation of the International Study Group for Pancreatic Surgery (ISGPS) Definition of Postpancreatectomy Acute Pancreatitis (PPAP)
- ClinicalTrials.gov ID
- NCT05680623
- Acronym / sponsor ID
- ISGPS-PPAP / 3822CESC
- Conditions
- Postoperative Acute Pancreatitis, Pancreaticoduodenectomy, Postoperative Pancreatic Fistula, Postoperative Complications
- Keywords
- pancreatitis, hyperamylasemia, pancreatoduodenectomy, postoperative complications, pancreatic fistula
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,900 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Heidelberg University, Catholic University of the Sacred Heart, Hospices Civils de Lyon, Lund University, Flinders Medical Centre, Amsterdam UMC, location VUmc, University of Dublin, Trinity College, Christchurch Hospital, University of Colorado, Denver, Scientific Institute San Raffaele, University of Graz, Technical University of Munich, Royal Free Hospital NHS Foundation Trust, San Gerardo Hospital, University of Liverpool, Universitätsklinikum Hamburg-Eppendorf, Massachusetts General Hospital, Kyushu University, The First Affiliated Hospital with Nanjing Medical University, Petz Aladar County Teaching Hospital, Mayo Clinic, Hospital Miguel Servet, Tata Memorial Hospital, Medical University of Vienna, Kyoto University, Graduate School of Medicine, UnitedHealth Group, Ludwig-Maximilians - University of Munich, Thomas Jefferson University, Humanitas Hospital, Italy, Indiana University Health, University of Manchester, New York University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 11 Jan 2023 (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 prospective validation study aims to investigate the incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system, to demonstrate its clinical impact by examining associated postoperative outcomes, and to validate its applicability through an economic assessment.
Detailed description
The study will be conducted at approximately 37 investigative sites in Europe, Asia, Oceania, and the United States. Only high volume centers for Pancreatic Surgery will be included in the study. All patients scheduled to receive elective pancreaticoduodenectomy (PD Kausch-Whipple or Longmire-Traverso) for all type of pancreatic disease (benign, malignant, or premalignant) will be enrolled. The study duration per subject will be up to 30 days after surgery or all the in-hospital lengths of stay. Preoperative care will follow institutional standards, according to each center involved. Surgical resection and reconstruction will be carried out according to the techniques adopted by each participating center. Both patients undergoing open and minimally invasive surgery can be considered eligible. Postoperative management will follow the institutional standards of each center. Serum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days (POD) 1 and 2.Serum C-reactive protein (CRP) will be measured according to each institutional policy and reported once assessed from POD 1 to 3. Drain fluid amylase, or lipase activity will be checked according to the Institutional standards of each involved, and the values will be retrieved whether assessed from POD 1 to five. Radiological imaging will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious for abdominal complications.The severity of complications will be assessed according to the Clavien-Dindo (CD) classification system 32 . Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery. Length of hospital stay is calculated from the day of surgery to discharge. Preoperative, intra-operative, and postoperative data will be recorded prospectively.
The estimated study duration will be 15 months. Time for data analysis must be considered negligible. Patients' follow-up will last 30 days after surgery to catch any additional morbidity even after discharge from the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | Diagnostic Test: PPAP diagnosisSubgroups based on the ISGPS diagnostic criteria and the grading system of PPAP: 1. Without PPAP or POH: Patients without POH nor imaging consistent with AP. 2. POH: sustained postoperative serum hyperamylasemia neither clinically relevant nor consistent imaging 3. PPAP: requiring the fulfilment of three criteria: * POH: sustained serum hyperamylasemia greater than the institutional upper limit of normal persisting on postoperative days 1 and 2; * macroscopic radiologic features of AP * clinically relevant complications. PPAP severity will be classified into grades B and C, with progressive clinical deterioration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled to receive elective pancreaticoduodenectomy (PD - Kausch-Whipple or Longmire-Traverso) for all type of pancreatic disease (benign, malignant, or premalignant) will be enrolled.
Key inclusion criteria (5 listed)
- Scheduled for elective PD;
- Male and females ≥ 18 years;
- Upfront or after neoadjuvant therapy surgery is allowed;
- The ability of the subject to understand the character and individual consequences of the clinical trial;
- Written informed consent.
Key exclusion criteria (4 listed)
- Patients undergoing emergency surgery;
- Informed consent withdrawal;
- Inability to perform the resection for any reason;
- Total or distal pancreatectomy.
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 |
|---|---|---|
| PPAP diagnosisSerum amylase (total or the pancreatic isoform) and/or lipase activity will be systematically measured at least on postoperative days 1 and 2. A CT with pancreas protocol iv contrast infusion will be performed in the postoperative course when clinically required, facing patients' clinical worsening, suspicious of abdominal complications. | Diagnostic test | study population |
Primary outcome
The incidence of PPAP
Time frame: 30 postoperative days
The incidence of PPAP after pancreaticoduodenectomy (PD) by applying the ISGPS definition and grading system.
The incidence of unplanned ICU admissions and hospital readmission in the PPAP group compared to the non-PPAP one.
Time frame: 30 postoperative days
Only an unplanned need for intensive care will be defined as intensive care unit (ICU) stay. Readmission will be defined as a new hospital admission after discharge within 30 days from index surgery.
The difference in length of hospital stay between the PPAP and the non-PPAP group
Time frame: up to hospital discharge, an average of 30 postoperative days
Length of hospital stay is calculated from the day of surgery to discharge.
The difference in hospital costs among the different grades of severity according to the ISGPS grading system22: no PPAP or POH, POH, PPAP grade B, and PPAP grade C groups.
Time frame: 30 postoperative days
Total hospital costs will comprise the cost of the index admission and every surgery-related readmission within 30 days from the index surgery. Costs will be inflation-adjusted using the standardized national consumer price index and normalized to adjust the variability inherent to different health systems and institutions.
4 secondary outcomes
Correlation between postoperative serum amylase/serum lipase activity (U/L) and radiologic feature consistent with PPAP retrieved at postoperative imaging.
Time frame: 30 postoperative days
Incidence and descriptive analysis of radiological features consistent with PAPP at postoperative imaging retrieved at different time points.
Time frame: 30 postoperative days
Incidence and severity of postoperative morbidity.
Time frame: 30 postoperative days
Incidence of postoperative mortality.
Time frame: 30 postoperative days
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 16 Jan 2024.
- Background: PubMed 34596077Marchegiani G, Barreto SG, Bannone E, Sarr M, Vollmer CM, Connor S, Falconi M, Besselink MG, Salvia R, Wolfgang CL, Zyromski NJ, Yeo CJ, Adham M, Siriwardena AK, Takaori K, Hilal MA, Loos M, Probst P, Hackert T, Strobel O, Busch ORC, Lillemoe KD, Miao Y, Halloran CM, Werner J, Friess H, Izbicki JR, Bockhorn M, Vashist YK, Conlon K, Passas I, Gianotti L, Del Chiaro M, Schulick RD, Montorsi M, Olah A, Fusai GK, Serrablo A, Zerbi A, Fingerhut A, Andersson R, Padbury R, Dervenis C, Neoptolemos JP, Bassi C, Buchler MW, Shrikhande SV; International Study Group for Pancreatic Surgery. Postpancreatectomy Acute Pancreatitis (PPAP): Definition and Grading From the International Study Group for Pancreatic Surgery (ISGPS). Ann Surg. 2022 Apr 1;275(4):663-672. doi: 10.1097/SLA.0000000000005226.
- Background: PubMed 30004917Bannone E, Andrianello S, Marchegiani G, Masini G, Malleo G, Bassi C, Salvia R. Postoperative Acute Pancreatitis Following Pancreaticoduodenectomy: A Determinant of Fistula Potentially Driven by the Intraoperative Fluid Management. Ann Surg. 2018 Nov;268(5):815-822. doi: 10.1097/SLA.0000000000002900.
- Background: PubMed 32981689Loos M, Strobel O, Dietrich M, Mehrabi A, Ramouz A, Al-Saeedi M, Muller-Stich BP, Diener MK, Schneider M, Berchtold C, Feisst M, Hinz U, Mayer P, Giannakis A, Schneider D, Weigand MA, Buchler MW, Hackert T. Hyperamylasemia and acute pancreatitis after pancreatoduodenectomy: Two different entities. Surgery. 2021 Feb;169(2):369-376. doi: 10.1016/j.surg.2020.07.050. Epub 2020 Sep 25.
- Background: PubMed 31831390Chen H, Wang W, Ying X, Deng X, Peng C, Cheng D, Shen B. Predictive factors for postoperative pancreatitis after pancreaticoduodenectomy: A single-center retrospective analysis of 1465 patients. Pancreatology. 2020 Mar;20(2):211-216. doi: 10.1016/j.pan.2019.11.014. Epub 2019 Nov 27.
- Background: PubMed 32291175Partelli S, Tamburrino D, Andreasi V, Mazzocato S, Crippa S, Perretti E, Belfiori G, Marmorale C, Balzano G, Falconi M. Implications of increased serum amylase after pancreaticoduodenectomy: toward a better definition of clinically relevant postoperative acute pancreatitis. HPB (Oxford). 2020 Nov;22(11):1645-1653. doi: 10.1016/j.hpb.2020.03.010. Epub 2020 Apr 11.
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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.
Giovanni Marchegiani principal investigator
Azienda Ospedaliera Universitaria Integrata di Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Acute Pancreatitis and Pancreaticoduodenectomy, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 5 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The incidence of PPAP (time frame: 30 postoperative days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680623, which also lists 5 linked publications.
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 16 Jan 2024.