Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections

Thoracic Diseases Clinical Trial

— EVALYMPH  

Official title:

Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799251
• Other study ID #: 1600010
• Status: Completed
• Start date: June 2016
• Est. completion date: July 2017

Study information

• Verified date: January 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis. The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery.

Description:

Postoperative infections are one of the most common complications in thoracic and digestive cancer surgery. Former studies have demonstrated that inflammatory response is altered during peri-operative period causing lymphopenia. It has been suggested that lymphopenia may contribute to postoperative infection. To date, no one has proved it in a multivariate analysis.

The aim of this study is to determine if lymphopenia is associated with postoperative infections in thoracic and digestive cancer surgery. It is a multicenter French cohort study. Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery before surgery (day-0) as well 1, 3, 5 and 8 days after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1125
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient undergoing digestive or thoracic cancer surgery under general anesthesia.

Exclusion Criteria:

• pregnant women,

• malignant blood disease,

• allograft patient,

• preoperative sepsis or preoperative systemic inflammatory response syndrome.

Related Conditions & MeSH terms

• Cancer of the Digestive System
• Digestive System Neoplasms
• Infection
• Lymphopenia
• Thoracic Diseases

Intervention

Other:
• Collection of plasma cell rate
Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery. The rates are assessed before surgery (day 0) and at days 1, 3, 5 and 8 after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.

Locations

Country	Name	City	State
France	Chu Angers	Angers
France	Hôpital Côtes de Nacre CHU CAEN	Caen
France	Hôpital Estaing CHU CLERMONT-FERRAND	Clermont-Ferrand
France	Hôpital Beaujon CHU PARIS 1	Clichy
France	Hôpital Michallon CHU GRENOBLE	La Tronche
France	Hôpital Huriez CHRU LILLE	Lille
France	Hôpital Edouard Herriot CHU LYON	Lyon
France	Hôpital La croix Rousse CHU LYON	Lyon
France	Hôpital Lyon Sud CHU LYON	Lyon
France	Hôpital La Timone CHU MARSEILLE	Marseille
France	Hôpital Nord CHU MARSEILLE	Marseille
France	Hôpital Hôtel-Dieu CHU NANTES	Nantes
France	Hôpital Carémeau CHU NIMES	Nîmes
France	Hôpital Bichat CHU PARIS 2	Paris
France	Hôpital La pitié-Salpetrière CHU PARIS 3	Paris
France	Hôpital Saint Louis-Lariboisière CHU PARIS 5	Paris
France	Hôpital Saint-Antoine CHU PARIS 4	Paris
France	Hôpital Pontchaillou CHU RENNES	Rennes
France	Hôpital Central CHRU STRASBOURG	Strasbourg
France	Centre de Lutte contre le Cancer, TOULOUSE	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of post operative infection	Patients undergoing general anesthesia for thoracic or digestive surgery could present lymphopenia. In this situation, the presence of post operative infection is notified. The correlation between lymphopenia and post operative infections is studied.	1 month
Secondary	Anesthetic and surgical parameters	To identify anesthetic and surgical parameters influencing postoperative lymphocytes cells count.	1 month