NCT04724551

Brief Summary

There is still no consensus on whether drain fluid amylase (DFA) level, C-reactive protein (CRP) level, or complex scores predict clinically relevant postoperative pancreatic fistula (CR-POPF). The aim of this study is to determine the accuracy of simple biochemical parameters (leucocytes, neutrophils, lymphocytes, Neutrophil to Lymphocytes Ratio (NLR), at postoperative days 1 and 3) to exclude the diagnosis of CR-POPF.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
648

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Longer than P75 for all trials

Status
completed

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

June 1, 2012

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 26, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2021

Completed
Last Updated

May 28, 2021

Status Verified

January 1, 2021

Enrollment Period

8.6 years

First QC Date

January 19, 2021

Last Update Submit

May 26, 2021

Conditions

Pancreas Neoplasm

Keywords

Pancreatic fistulaNeutrophil-to-Lymphocyte RatioPancreatoduodenectomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of clinically relevant pancreatic fistula

    Clinically relevant postoperative pancreatic fistula according to the 2016 International Study Group of Pancreatic Surgery definition

    at hospital discharge assessed up to 30 days

Secondary Outcomes (1)

  • Biological markers

    Postoperative day one and three

Interventions

pancreatoduodenectomy (PD)PROCEDURE

A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.

Eligibility Criteria

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

3 cohorts, which were as follows: the set of 451 patients was randomly sampled following a ratio 2:1 into a training (n=301) and a validation (n=150) cohort to respectively determine and validate the accuracy, best timing, and cut-off for the surrogate markers, then validated in an external cohort (n=197).

You may qualify if:

  • Patients who underwent pancreatoduodenectomy

You may not qualify if:

  • Total pancreatectomy
  • Enucleation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatic Fistula

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesDigestive System FistulaFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Olivier Turrini, PD

    Institut Paoli-Calmettes- (IPC)

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 19, 2021

First Posted

January 26, 2021

Study Start

June 1, 2012

Primary Completion

December 31, 2020

Study Completion

February 28, 2021

Last Updated

May 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share