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Early POstoperative BIomarkers in PancreatoDuodenectomy: a Spanish Nationwide Study

NCT04342923 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 525

Last updated 2021-06-11

No results posted yet for this study

Summary

AIMS: To recruit a large nationwide Spanish series in order to register PF rate and other common morbidity after PD, and to perform external validation of the aforementioned score, as well as to analyze other postoperative blood parameters and biomarkers associated with complications.

METHODS: Observational prospective and multicentric cohort study to perform external validation of the above-mentioned score. All Spanish centers/units performing PD are invited to include participants. Patients will be consecutively recruited during an 8-10 months period, regardless of their annual volume of pancreatic surgery.

Study variables will be hemogram parameters on POD1 and POD2 (specifically lymphocytes), other parameters and biomarkers (RCP, lactate, procalcitonin, amylase, lipase, albumin) and the common variables concerning PD studies.

LIMITATIONS: Heterogeneity in perioperative management and in blood analysis measuring since this is a multicenter study. Possibility of underestimating the PF rate in patients without surgical drainage. Finally, the cases of mini-invasive approach or pancreatogastrostomy will receive a specific subgroup analysis since the score was designed on a series of open PD and pancreatojejunostomy.

Conditions

  • Pancreaticoduodenectomy

Interventions

OTHER

No intervention

Blood analysis

Sponsors & Collaborators

  • Hospital Clínico Universitario de Valladolid

    lead OTHER

Principal Investigators

  • Mario Rodriguez-Lopez, MD, PhD · Hospital Clinico Universitario de Valladolid (España)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2022-03-31
Completion
2022-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04342923 on ClinicalTrials.gov