Pancreatic AdenocarcinomaPAADNCT06893536
Impact of Perioperative Nutritional Status and Management in the Context of Resectable Pancreatic Adenocarcinoma
An observational study of Pancreatic Adenocarcinoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients with pancreatic adenocarcinoma are frequently in a situation of malnutrition, in a context of functional alteration of the digestive tract, and hypercatabolism. As a result, nutritional support is frequently necessary perioperatively, but currently does not follow a specific protocol, and without… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Adenocarcinoma
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2023to 12 Oct 2025
- 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
- Adult, Older adult
Study population: Major subject (≥18 years old) with pancreatic adenocarcinoma authenticated by pathology and operated on in the visceral and digestive surgery department, NHC Strasbourg, during the period from January 1, 2018 to December 31, 2022
Who may be able to join
- Major subject (≥18 years old)
- Subject with pancreatic adenocarcinoma authenticated by pathology
- Subject candidate for curative surgical treatment
- Subject operated on in the visceral and digestive surgery department, NHC Strasbourg, during the period from January 1, 2018 to December 31, 2022
- Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.
Who cannot join
- Subject having expressed opposition to participating in the study
- Subject presenting a metastatic form or one not accessible to surgical treatment considered curative of pancreatic adenocarcinoma
- Subject under guardianship or curatorship
- Subje
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Viscérale et Digestive - CHU de Strasbourg - France
Strasbourg, 67091
Zineb CHERKAOUI, MD, 33 3 69 55 13 15, zineb.cherkaoui@chru-strasbourg.fr
Zineb CHERKAOUI, MD
About this study
Patients with pancreatic adenocarcinoma are frequently in a situation of malnutrition, in a context of functional alteration of the digestive tract, and hypercatabolism.
As a result, nutritional support is frequently necessary perioperatively, but currently does not follow a specific protocol, and without coordination.
It then appears the need to evaluate the prevalence of malnutrition, its impact on perioperative morbidity and mortality, and current management methods.
Depending on the findings, subsequent interventional studies will be carried out on the subject, exploring the different modalities of artificial nutrition.
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic Adenocarcinoma, Digestive tract, Hypercatabolism, Malnutrition,
- Medical subject headings
- Malnutrition
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the Severity of Perioperative Malnutrition in Pancreatic Adenocarcinoma
The CCI score measures a patient's postoperative outcome based on the number and severity of complications occurring on a scale of 0 to 100:
0: No complications 100: Death
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start12 Oct 2023
- Primary completionOct 2025 (estimated)
- Study completion12 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06893536
- Sponsor's protocol ID
- 9062
- Acronym
- PAAD
- Status last verified
- Jul 2024
- First submitted
- 4 Jul 2024
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Perioperative Nutritional Status and Management in the Context of Resectable Pancreatic Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06893536
- Acronym / sponsor ID
- PAAD / 9062
- Conditions
- Pancreatic Adenocarcinoma
- Keywords
- Pancreatic Adenocarcinoma, Digestive tract, Hypercatabolism, Malnutrition,
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- 12 Oct 2025 (estimated)
- First posted
- 25 Mar 2025 (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 with pancreatic adenocarcinoma are frequently in a situation of malnutrition, in a context of functional alteration of the digestive tract, and hypercatabolism.
As a result, nutritional support is frequently necessary perioperatively, but currently does not follow a specific protocol, and without coordination.
It then appears the need to evaluate the prevalence of malnutrition, its impact on perioperative morbidity and mortality, and current management methods.
Depending on the findings, subsequent interventional studies will be carried out on the subject, exploring the different modalities of artificial nutrition.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) with pancreatic adenocarcinoma authenticated by pathology and operated on in the visceral and digestive surgery department, NHC Strasbourg, during the period from January 1, 2018 to December 31, 2022
Key inclusion criteria (5 listed)
- Major subject (≥18 years old)
- Subject with pancreatic adenocarcinoma authenticated by pathology
- Subject candidate for curative surgical treatment
- Subject operated on in the visceral and digestive surgery department, NHC Strasbourg, during the period from January 1, 2018 to December 31, 2022
- Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.
Key exclusion criteria (4 listed)
- Subject having expressed opposition to participating in the study
- Subject presenting a metastatic form or one not accessible to surgical treatment considered curative of pancreatic adenocarcinoma
- Subject under guardianship or curatorship
- Subje
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
Study of the Severity of Perioperative Malnutrition in Pancreatic Adenocarcinoma
Time frame: Up to 1 year
The CCI score measures a patient's postoperative outcome based on the number and severity of complications occurring on a scale of 0 to 100: 0: No complications 100: Death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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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.
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 Adenocarcinoma, run by University Hospital, Strasbourg, France at 1 site in France.
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: status not confirmed, as of the sponsor's last update on 25 Mar 2025. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zineb CHERKAOUI, MD (33 3 69 55 13 15, zineb.cherkaoui@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the Severity of Perioperative Malnutrition in Pancreatic Adenocarcinoma (time frame: Up to 1 year). 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 25 Mar 2025.