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Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management

NCT04380506 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2020-05-08

No results posted yet for this study

Summary

Pancreatic fistula (PF) represents the Achille's heel of pancreatic surgery and is the main cause of postoperative morbidity since it can determine the onset of others complications such as abdominal abscesses, surgical wound infections, sepsis and bleeding, that can sometimes be fatal.

During a previous study conducted at the University Campus Bio-Medico of Rome, Department of General Surgery there were identified cut-offs of amylase levels on the abdominal drainage fluid dosed in I postoperative day (POD1) and III postoperative day (POD3) which can significantly predict PF and in particular clinically relevant fistulas as well as abdominal collections and biliary fistulas, if related to some specific findings of the abdominal CT routine performed in POD3.

The aim of this research project is to validate the cut-offs of the amylase levels on drainage fluid identified during the previous research in order to identify patients at risk of clinically relevant PF and to validate the use of abdomen CT without contrast in POD3 in patients with increased risk of biliary fistula.

Conditions

  • Pancreas Cancer
  • Pancreatic Fistula

Interventions

PROCEDURE

Surgical Drains Management

The Role of Amylase Drain Level in the Management of Surgical Drains after Pancreratoduodenectomy

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Damiano Caputo, MD · Campus Bio-Medico University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-15
Primary Completion
2021-06-01
Completion
2021-09-01

Countries

  • Italy

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 NCT04380506 on ClinicalTrials.gov