Cancer of the Digestive SystemEVALYMPHNCT02799251
Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections
An observational study of Cancer of the Digestive System and Thoracic Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of the Digestive System, Thoracic Diseases
- What is being tested?
- Collection of plasma cell rate
- How many people
- 1,125 participants
- Where
- 20 sitesFrance
- Study dates
- Jun 2016to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia.
Who may be able to join
- patient undergoing digestive or thoracic cancer surgery under general anesthesia.
Who cannot join
- pregnant women,
- malignant blood disease,
- allograft patient,
- preoperative sepsis or preoperative systemic inflammatory response syndrome.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
France20 sites
Chu Angers
Angers, 49100
Hôpital Côtes de Nacre CHU CAEN
Caen, 14003
Hôpital Estaing CHU CLERMONT-FERRAND
Clermont-Ferrand, 63100
Hôpital Beaujon CHU PARIS 1
Clichy, 92110
Hôpital Michallon CHU GRENOBLE
La Tronche, 38700
Hôpital Huriez CHRU LILLE
Lille, 59037
Hôpital Edouard Herriot CHU LYON
Lyon, 69000
Hôpital La croix Rousse CHU LYON
Lyon, 69000
Hôpital Lyon Sud CHU LYON
Lyon, 69000
Hôpital Nord CHU MARSEILLE
Marseille, 13015
Hôpital La Timone CHU MARSEILLE
Marseille, 13385
Hôpital Hôtel-Dieu CHU NANTES
Nantes, 44000
Hôpital Carémeau CHU NIMES
Nîmes, 30029
Hôpital Saint Louis-Lariboisière CHU PARIS 5
Paris, 75010
Hôpital Saint-Antoine CHU PARIS 4
Paris, 75012
Hôpital La pitié-Salpetrière CHU PARIS 3
Paris, 75013
Hôpital Bichat CHU PARIS 2
Paris, 75018
Hôpital Pontchaillou CHU RENNES
Rennes, 35000
Hôpital Central CHRU STRASBOURG
Strasbourg, 67000
Centre de Lutte contre le Cancer, TOULOUSE
Toulouse, 31000
About this study
Official title: Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study
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.
Read the detailed 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.
- Conditions
- Cancer of the Digestive System, Thoracic Diseases
- Being tested
- Collection of plasma cell rate
- Keywords
- lymphopenia, postoperative infection, thoracic cancer surgery, digestive cancer surgery
- Medical subject headings
- Digestive System Neoplasms, Thoracic Diseases, Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of plasma cell rateOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Collection of plasma cell rate | Post operative infections and their association with lymphopenia are assessed in this study for patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia. Receives: Other: Collection of plasma cell rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
Secondary outcomes (1)
Anesthetic and surgical parameters
To identify anesthetic and surgical parameters influencing postoperative lymphocytes cells count.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer of the Digestive SystemStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,125 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Serge Molliex, PhD, Principal investigator, CHU de Saint-Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799251
- Sponsor's protocol ID
- 1600010
- Acronym
- EVALYMPH
- Status last verified
- Jan 2021
- First submitted
- 10 Jun 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Petit L, Pastene B, Dupont G, Baffeleuf B, Goulevant PA, Fellahi JL, Gricourt Y, Lebuffe G, Ouattara A, Fischer MO, Mertes PM, Eyraud D, Bouhemad B, Gomola A, Montravers P, Alingrin J, Flory L, Incagnoli P, Boisson M, Leone M, Monneret G, Lukaszewicz AC, Pereira B, Molliex S; for the EVALYMPH study group. Postoperative lymphopaenia as a risk factor for postoperative infections in cancer surgery: A prospective multicentre cohort study (the EVALYMPH study). Eur J Anaesthesiol. 2025 Mar 1;42(3):244-254. doi: 10.1097/EJA.0000000000002089. Epub 2024 Oct 29.
PubMed 39474711
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Lymphopenia as Risk Factor for Postoperative Infections: EVALYMPH Study
- ClinicalTrials.gov ID
- NCT02799251
- Acronym / sponsor ID
- EVALYMPH / 1600010
- Conditions
- Cancer of the Digestive System, Thoracic Diseases
- Keywords
- lymphopenia, postoperative infection, thoracic cancer surgery, digestive cancer surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,125 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collection of plasma cell rate | – | Other: Collection of plasma cell ratePost operative infections and their association with lymphopenia are assessed in this study for patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age undergoing digestive or thoracic cancer surgery under general anesthesia.
Key inclusion criteria (1 listed)
- patient undergoing digestive or thoracic cancer surgery under general anesthesia.
Key exclusion criteria (4 listed)
- pregnant women,
- malignant blood disease,
- allograft patient,
- preoperative sepsis or preoperative systemic inflammatory response syndrome.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of plasma cell rateLymphocytes 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. | Other | Collection of plasma cell rate |
Primary outcome
Presence of post operative infection
Time frame: 1 month
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 secondary outcome
Anesthetic and surgical parameters
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 39474711Petit L, Pastene B, Dupont G, Baffeleuf B, Goulevant PA, Fellahi JL, Gricourt Y, Lebuffe G, Ouattara A, Fischer MO, Mertes PM, Eyraud D, Bouhemad B, Gomola A, Montravers P, Alingrin J, Flory L, Incagnoli P, Boisson M, Leone M, Monneret G, Lukaszewicz AC, Pereira B, Molliex S; for the EVALYMPH study group. Postoperative lymphopaenia as a risk factor for postoperative infections in cancer surgery: A prospective multicentre cohort study (the EVALYMPH study). Eur J Anaesthesiol. 2025 Mar 1;42(3):244-254. doi: 10.1097/EJA.0000000000002089. Epub 2024 Oct 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serge Molliex, PhD principal investigator
CHU de Saint-Etienne
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer of the Digestive System and Thoracic Diseases, run by Centre Hospitalier Universitaire de Saint Etienne at 20 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of post operative infection (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02799251, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.