Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer

Study Overview
=================
Brief Summary
-----------------
Esophageal surgery is a complex surgery, with high post-operative morbidity and mortality. The incidence of complications associated with esophagectomy varies from 17% to 74%, in the literature. A section of vagus nerves is conventionally performed during esophagectomy for cancer, because of oncological margins. The vagus nerve is responsible for the parasympathetic innervation at the gastrointestinal level, but also at the cardiac and pulmonary level. The post-operative morbidity of these procedures could be linked in part to the bilateral section of the vagus nerves, because of their impact on the autonomous regulation of this vital functions. The main objective of the study is to find a modification of the sympathomimetic balance pre and post operatively, in patients undergoing esophagectomy.

Detailed Description
-----------------
The sympathomimetic balance was measured using a Holter-ECG heart rate monitor. The parameters collected were used to calculate the variability of the heart rate, the high frequencies (HF, reflection of the parasympathetic system), the low frequencies (LF, reflection of the sympathetic system and the parasympathetic system) and the ratio // LF / HF (reflection of the sympathetic activity) thanks to Fourier analysis and the use of HRVanalysis software. The measurements were taken at night, to overcome the great sympathomimetic variabilities due to external stimulations during the day: one night 3 month before surgery/before the first chemotherapy, one night between 2 and 4 weeks before hospitalization (remotely of possible chemotherapy), the night before the intervention (context of hospitalization and preoperative stress), one night between D7 and D10 (context of hospitalization, and distance from anesthetic drugs), one night at home between 4 and 8 weeks post-operative, and one night at home at 3 months post-operative. The measurements were therefore not carried out the first nights following the intervention to overcome the anesthetic drugs that affect the balance of the autonomic nervous system. A baroreflex measurement was carried out at the patient's entrance, the day before the intervention, during hospitalization, and the day of discharge. This measure was renewed at 3 months. A measurement of patient activity was carried out preoperatively by wearing an actimeter watch for 1 week then renewed at 3 months. A Respiratory Functional Exploration associated with a stress test with calculation of the VO2max is systematically carried out before the esophageal surgery. A Respiratory Functional Exploration was renewed 4 to 8 weeks after the intervention, and then at 3 months. the 6-minute walk test was performed at the same time.

Official Title
-----------------
Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Holter ECG
* Behavioral: Questionary
* Diagnostic Test: Pupillometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Esophagectomy for cancer written and oral agreement Exclusion Criteria: pregnant women, patients with permanent atrial fibrillation, patients with pace-maker Patients under guardianship/curatorship

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Holter ECG|Measurement of the modification of the sympathomimetic balance|
|Behavioral: Questionary|Lifestyle questionary (time spent in front of television, physical activity)|
|Diagnostic Test: Pupillometry|Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of Standard deviation of all NN (SDNN) (ms) | Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery | before surgery | 
| Analysis of Standard deviation of all NN (SDNN) (ms) | Analysis of Standard deviation of all NN (SDNN) intervals, over the entire registration period, provides information on global variability. Measured by Holter results. Day 0 = surgery | day 7 to day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HF activity | Day 0 = surgery measured with the Holter Electrocardiogram | before surgery : Day -82, Day -30, Day -1 | 
| LF activity | Day 0 = surgery measured with the Holter Electrocardiogram | before surgery : Day -82, Day -30, Day -1 | 
| LF/HF ratio | Day 0 = surgery measured with the Holter Electrocardiogram | before surgery : Day -82, Day -30, Day -1 | 
| HF activity | Day 0 = surgery measured with the Holter Electrocardiogram | after surgery : day 7, day 60, day 90 | 
| LF activity | Day 0 = surgery measured with the Holter Electrocardiogram | after surgery : day 7, day 60, day 90 | 
| LF/HF ratio | Day 0 = surgery measured with the Holter Electrocardiogram | after surgery : day 7, day 60, day 90 | 
| change in baroreflex | baroreflex sensitivity : ms/mmHg Day 0 = surgery | Day -1, Day 7, day discharge, day 90 | 
| modify the respiratory functional exploration | Peak expiratory volume per second : L Day 0 = surgery | Day -30, Day 30, Day 60 | 
| intraoperative pupillometry | pupillary diameter : mm | during surgery | 
| physical capacity | walking distance in 6 minutes Day 0 = surgery | Day-30, Day 30, Day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagectomy, surgery, Holter-ECG