NCT04342923

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
525

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
11 months until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 11, 2021

Status Verified

June 1, 2021

Enrollment Period

1 year

First QC Date

April 9, 2020

Last Update Submit

June 9, 2021

Conditions

Pancreaticoduodenectomy

Keywords

PANCREATICODUODENECTOMYCOMPLICATIONSPANCREATIC FISTULASCOREBIOMARKERS

Outcome Measures

Primary Outcomes (1)

  • Pancreatic fistula rate

    Pancreatic fistula including biochemical, grade B and grade C according to ISGPS updated criteria 2016

    90 days since PD

Secondary Outcomes (5)

  • Clinically relevant pancreatic fistula

    90 days since PD

  • Overall complications

    90 days since PD

  • Severe morbidity

    90 days since PD

  • Mortality

    90 days since PD

  • Comprehensive Complication Index

    90 days since PD

Study Arms (1)

Complete cohort

All patients undergoing PD during study period in all participating center/units in Spain.

Other: No intervention

Interventions

No interventionOTHER

Blood analysis

Complete cohort

Eligibility Criteria

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

Patients undergoing PD in Spain

You may qualify if:

  • benign or malignant condition requiring surgical treatment by PD.
  • Signing the informed consent form

You may not qualify if:

  • Intra-operative findings of unresectability (pancreatic resection not be completed or palliative procedure performed)
  • Other types of pancreatic resection (enucleations, distal and total pancreatectomies), as well as multivisceral resective procedures.
  • Intraoperative radiotherapy
  • ASA IV patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico Universitario

Valladolid, 47003, Spain

RECRUITING

Related Publications (1)

  • Rodriguez-Lopez M, Tejero-Pintor FJ, Bailon-Cuadrado M, Barrera-Rebollo A, Perez-Saborido B, Pacheco-Sanchez D. Impaired immune reaction and increased lactate and C-reactive protein for early prediction of severe morbidity and pancreatic fistula after pancreatoduodenectomy. Hepatobiliary Pancreat Dis Int. 2020 Feb;19(1):58-67. doi: 10.1016/j.hbpd.2019.05.003. Epub 2019 May 20.

    PMID: 31153788RESULT

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Mario Rodriguez-Lopez, MD, PhD

    Hospital Clinico Universitario de Valladolid (España)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mario Rodriguez-Lopez, MD, PhD

CONTACT

983420000mariorodriguezlopez@gmail.com

Carlos A Jezieniecki-Fernandez, MD

CONTACT

983420000carlos.jezieniecki@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General and Digestive Surgeon, MD, PhD

Study Record Dates

First Submitted

April 9, 2020

First Posted

April 13, 2020

Study Start

March 1, 2021

Primary Completion

March 1, 2022

Study Completion

May 1, 2022

Last Updated

June 11, 2021

Record last verified: 2021-06

Locations

ES(1)