Pancreatic and Peripancreatic TumorsNCT05608538
Evaluation of Nutritional Scores as Predictive Factors of Postoperative Outcome After Pancreatic Surgery
An observational study of Pancreatic and Peripancreatic Tumors, run by Universita di Verona at 1 site in Italy.
Trial summary
Patients scheduled for major pancreatic surgery will be screened for malnutrition by five screening scores chosen depending on their clinical applicability. After surgery, it will be evaluated which score predicts the best complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic and Peripancreatic Tumors
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 15 Sep 2022to 30 Apr 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: The population of the study consists of consecutive patients, aged between 18 and 90, that will undergo major pancreatic surgery at the General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital.
Who may be able to join
- Patients aged between 18 and 90 years undergoing major pancreatic resections (pancreaticoduodenectomy, distal pancreatic resection, total pancreatic resection) are eligible for inclusion. All patients are informed orally about all aspects of the trial. All conditions leading to primary pancreatic resection are eligible.
Who cannot join
- patients undergoing minor pancreatic resections.
Trial locations and contacts
1 site in 1 country.
Italy1 site
General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital
Verona, 37134
About this study
Patients scheduled for major pancreatic surgery will be screened for malnutrition by five screening scores chosen depending on their clinical applicability. After surgery, it will be evaluated which score predicts the best complications.
Read the detailed description
Patients scheduled for major pancreatic surgery (pancreaticoduodenectomy, distal resection, total resection) will be screened for malnutrition by the following screening scores: Nutritional Risk Screening Score 2002; Subjective Global Assessment; Malnutrition Universal Screening Tool; Mini Nutritional Assessment and Short Nutritional Assessment Questionnaire.
The postoperative outcome will be recorded, and the predictive value of each score will be calculated.
- Conditions
- Pancreatic and Peripancreatic Tumors
- Keywords
- Pancreatic cancer, Pancreaticoduodenotomy, Nutritional assessment score, Malnutrition, Pancreatic surgery, Distal resection, Total resection, Oncology, Clinica trial
- Medical subject headings
- Pancreatic Neoplasms, Malnutrition, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of nutritional assessment score as predictive of pancreatic surgery outcomes
Five nutritional questionnaires are administered to each patient to assess their nutritional status and then evaluate if there is a correlation between them and the postoperative outcomes.
Measured: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.
Secondary outcomes (1)
The correlation between nutritional scores and postoperative outcomes is based on age, type of disease, possible preoperative oncological treatments, and operation technique.
Association of each score with postoperative outcomes depending on certain patient's characteristics:age,type of disease,operation technique (open surgery versus laparoscopy)
Measured: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start15 Sep 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic and Peripancreatic TumorsStudies 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
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Paiella, MD, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608538
- Sponsor's protocol ID
- NutriPanc
- Status last verified
- May 2024
- First submitted
- 1 Nov 2022
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paiella S, Secchettin E, Azzolina D, De Pastena M, Gentilini N, Trestini I, Casciani F, Sandini M, Lionetto G, Milella M, Malleo G, Gianotti L, Gregori D, Salvia R. Evaluation of five nutritional scores as predictors of postoperative outcome following pancreatic resection: A prospective, single-center study. Clin Nutr ESPEN. 2024 Oct;63:635-641. doi: 10.1016/j.clnesp.2024.07.014. Epub 2024 Jul 24.
PubMed 39053696
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Nutritional Scores as Predictive Factors of Postoperative Outcome After Pancreatic Surgery
- ClinicalTrials.gov ID
- NCT05608538
- Acronym / sponsor ID
- NutriPanc
- Conditions
- Pancreatic and Peripancreatic Tumors
- Keywords
- Pancreatic cancer, Pancreaticoduodenotomy, Nutritional assessment score, Malnutrition, Pancreatic surgery, Distal resection, Total resection, Oncology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 8 Nov 2022 (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.
Patients scheduled for major pancreatic surgery will be screened for malnutrition by five screening scores chosen depending on their clinical applicability. After surgery, it will be evaluated which score predicts the best complications.
Detailed description
Patients scheduled for major pancreatic surgery (pancreaticoduodenectomy, distal resection, total resection) will be screened for malnutrition by the following screening scores: Nutritional Risk Screening Score 2002; Subjective Global Assessment; Malnutrition Universal Screening Tool; Mini Nutritional Assessment and Short Nutritional Assessment Questionnaire.
The postoperative outcome will be recorded, and the predictive value of each score will be calculated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population of the study consists of consecutive patients, aged between 18 and 90, that will undergo major pancreatic surgery at the General and Pancreatic Surgery Unit, Pancreas Institute, University of Verona Hospital.
Key inclusion criteria (1 listed)
- Patients aged between 18 and 90 years undergoing major pancreatic resections (pancreaticoduodenectomy, distal pancreatic resection, total pancreatic resection) are eligible for inclusion. All patients are informed orally about all aspects of the trial. All conditions leading to primary pancreatic resection are eligible.
Key exclusion criteria (1 listed)
- patients undergoing minor pancreatic resections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of nutritional assessment score as predictive of pancreatic surgery outcomes
Time frame: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.
Five nutritional questionnaires are administered to each patient to assess their nutritional status and then evaluate if there is a correlation between them and the postoperative outcomes.
1 secondary outcome
The correlation between nutritional scores and postoperative outcomes is based on age, type of disease, possible preoperative oncological treatments, and operation technique.
Time frame: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.
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 7 May 2024.
- Derived from this study: PubMed 39053696Paiella S, Secchettin E, Azzolina D, De Pastena M, Gentilini N, Trestini I, Casciani F, Sandini M, Lionetto G, Milella M, Malleo G, Gianotti L, Gregori D, Salvia R. Evaluation of five nutritional scores as predictors of postoperative outcome following pancreatic resection: A prospective, single-center study. Clin Nutr ESPEN. 2024 Oct;63:635-641. doi: 10.1016/j.clnesp.2024.07.014. Epub 2024 Jul 24.
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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.
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 Pancreatic and Peripancreatic Tumors, run by Universita di 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 1 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 7 May 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?
Evaluation of nutritional assessment score as predictive of pancreatic surgery outcomes (time frame: The nutritional assessment scores are administred between 15 and 1 day before the operation. The evaluation of outcomes ends when patient are dismissed.). 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 NCT05608538, which also lists 1 linked publication.
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 7 May 2024.