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

Esophageal Cancer Clinical Trial

— PROSNACO  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04835987
• Other study ID #: 20CH250
• Secondary ID: 2020-A03326-33
• Status: Withdrawn
• Start date: December 2023
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint-Etienne	Saint-Étienne

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