NCT06893536

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2024

Completed
9 months until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2025

Completed
Last Updated

March 25, 2025

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

July 4, 2024

Last Update Submit

March 24, 2025

Conditions

Keywords

Pancreatic AdenocarcinomaDigestive tractHypercatabolismMalnutrition,

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 1 year

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Viscérale et Digestive - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2024

First Posted

March 25, 2025

Study Start

October 12, 2023

Primary Completion

October 1, 2025

Study Completion

October 12, 2025

Last Updated

March 25, 2025

Record last verified: 2024-07

Locations