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

NCT04835987 | Withdrawn

• 2 other identifiers: 20CH2502020-A03326-33
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer

Keywords

Esophagectomy; surgery; Holter-ECG

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• HF activity

  before surgery : Day -82, Day -30, Day -1

• LF activity

  before surgery : Day -82, Day -30, Day -1

• LF/HF ratio

  before surgery : Day -82, Day -30, Day -1

• HF activity

  after surgery : day 7, day 60, day 90

• LF activity

  after surgery : day 7, day 60, day 90

Interventions

Holter ECG DIAGNOSTIC_TEST

Measurement of the modification of the sympathomimetic balance

Questionary BEHAVIORAL

Lifestyle questionary (time spent in front of television, physical activity)

Pupillometry DIAGNOSTIC_TEST

Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

population aged over 18 years with esophagectomy for cancer

You may qualify if:

• Esophagectomy for cancer
• written and oral agreement

You may not qualify if:

• pregnant women,
• patients with permanent atrial fibrillation,
• patients with pace-maker
• Patients under guardianship/curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• EVE HUART, MD

  CHU ST ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 8, 2021
• Study Start: December 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 24, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)