An observational study in Esophageal Cancer, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-24.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Observational
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.
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.
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population aged over 18 years with esophagectomy for cancer
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Exclusion Criteria:
Measurement of the modification of the sympathomimetic balance
Lifestyle questionary (time spent in front of television, physical activity)
Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative.
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
Time frame: 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
Time frame: day 7 to day 90
HF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Time frame: before surgery : Day -82, Day -30, Day -1
LF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Time frame: before surgery : Day -82, Day -30, Day -1
LF/HF ratio
Day 0 = surgery measured with the Holter Electrocardiogram
Time frame: before surgery : Day -82, Day -30, Day -1
HF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Time frame: after surgery : day 7, day 60, day 90
LF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Time frame: after surgery : day 7, day 60, day 90
LF/HF ratio
Day 0 = surgery measured with the Holter Electrocardiogram
Time frame: after surgery : day 7, day 60, day 90
change in baroreflex
baroreflex sensitivity : ms/mmHg Day 0 = surgery
Time frame: Day -1, Day 7, day discharge, day 90
modify the respiratory functional exploration
Peak expiratory volume per second : L Day 0 = surgery
Time frame: Day -30, Day 30, Day 60
intraoperative pupillometry
pupillary diameter : mm
Time frame: during surgery
physical capacity
walking distance in 6 minutes Day 0 = surgery
Time frame: Day-30, Day 30, Day 90
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2023; primary completion for Mar 2024, 3 months later.
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This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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