Clinical trial NCT04835987: Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer
Official title: Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Esophageal Cancer
Keywords: Esophagectomy
surgery
Holter-ECG
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: population aged over 18 years with esophagectomy for cancer

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.

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

Primary outcomes:
measure: Analysis of Standard deviation of all NN (SDNN) (ms)
timeFrame: before surgery
measure: Analysis of Standard deviation of all NN (SDNN) (ms)
timeFrame: day 7 to day 90
Secondary outcomes:
measure: HF activity
timeFrame: before surgery : Day -82, Day -30, Day -1
measure: LF activity
timeFrame: before surgery : Day -82, Day -30, Day -1
measure: LF/HF ratio
timeFrame: before surgery : Day -82, Day -30, Day -1
measure: HF activity
timeFrame: after surgery : day 7, day 60, day 90
measure: LF activity
timeFrame: after surgery : day 7, day 60, day 90
measure: LF/HF ratio
timeFrame: after surgery : day 7, day 60, day 90
measure: change in baroreflex
timeFrame: Day -1, Day 7, day discharge, day 90
measure: modify the respiratory functional exploration
timeFrame: Day -30, Day 30, Day 60
measure: intraoperative pupillometry
timeFrame: during surgery
measure: physical capacity
timeFrame: Day-30, Day 30, Day 90
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
Study officials:
affiliation: CHU ST ETIENNE
name: EVE HUART, MD
role: PRINCIPAL_INVESTIGATOR
References: