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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Diagnostic test: Holter ECG; Behavioral: Questionary; Diagnostic test: Pupillometry

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.

• Study Type: Observational
• Enrollment (Anticipated): 15

Contacts and Locations

• Study Contact: Name: EVE HUART, MD; Phone Number: 33 0)4 77 82 83 37; Email: eve.huart@chu-st-etienne.fr
• Study Contact Backup: Name: DAVID HUPIN, MC; Phone Number: 33 0)477127985; Email: david.hupin@chu-st-etienne.fr

Study Locations

• France
  • Saint-Étienne, France, 42055
    • Centre Hospitalier Universitaire de Saint-Étienne
    • Sub-Investigator: Olivier TIFFET, MD PhD
    • Sub-Investigator: David HUPIN, MD
    • Contact: MARIE PEURIERE; Phone Number: +33 (0)4 77 12 08 26; Email: marie.peuriere@chu-st-etienne.fr
    • Principal Investigator: EVE HUART, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

population aged over 18 years with esophagectomy for cancer

Description

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

Study Plan

How is the study designed?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: EVE HUART, MD, CHU St Etienne

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2023
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): September 1, 2024

Study Registration Dates

• First Submitted: March 26, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: surgery; Esophagectomy; Holter-ECG
• Other Study ID Numbers: 20CH250; 2020-A03326-33 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No