Esophageal CancerPROSNACONCT04835987
Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer
An observational study of Esophageal Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Holter ECG, Questionary and Pupillometry
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2023to Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: population aged over 18 years with esophagectomy for cancer
Who may be able to join
- Esophagectomy for cancer
- written and oral agreement
Who cannot join
- pregnant women,
- patients with permanent atrial fibrillation,
- patients with pace-maker
- Patients under guardianship/curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: 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.
Read the 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.
- Conditions
- Esophageal Cancer
- Being tested
- Holter ECG, Questionary, Pupillometry
- Keywords
- Esophagectomy, surgery, Holter-ECG
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holter ECGDiagnostic test
Measurement of the modification of the sympathomimetic balance
QuestionaryBehavioural
Lifestyle questionary (time spent in front of television, physical activity)
PupillometryDiagnostic test
Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: day 7 to day 90
Secondary outcomes (10)
HF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Measured: before surgery : Day -82, Day -30, Day -1
LF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Measured: before surgery : Day -82, Day -30, Day -1
LF/HF ratio
Day 0 = surgery measured with the Holter Electrocardiogram
Measured: before surgery : Day -82, Day -30, Day -1
HF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Measured: after surgery : day 7, day 60, day 90
LF activity
Day 0 = surgery measured with the Holter Electrocardiogram
Measured: after surgery : day 7, day 60, day 90
LF/HF ratio
Day 0 = surgery measured with the Holter Electrocardiogram
Measured: after surgery : day 7, day 60, day 90
change in baroreflex
baroreflex sensitivity : ms/mmHg Day 0 = surgery
Measured: Day -1, Day 7, day discharge, day 90
modify the respiratory functional exploration
Peak expiratory volume per second : L Day 0 = surgery
Measured: Day -30, Day 30, Day 60
intraoperative pupillometry
pupillary diameter : mm
Measured: during surgery
physical capacity
walking distance in 6 minutes Day 0 = surgery
Measured: Day-30, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study startDec 2023 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionSep 2024 (estimated)
Why it stopped: Due to a lack of staff in the department, no inclusion could be realized.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EVE HUART, MD, Principal investigator, CHU ST ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835987
- Sponsor's protocol ID
- 20CH250
- Other IDs
- 2020-A03326-33
- Acronym
- PROSNACO
- Status last verified
- Jun 2023
- First submitted
- 26 Mar 2021
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer
- ClinicalTrials.gov ID
- NCT04835987
- Acronym / sponsor ID
- PROSNACO / 20CH250
- Conditions
- Esophageal Cancer
- Keywords
- Esophagectomy, surgery, Holter-ECG
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to a lack of staff in the department, no inclusion could be realized.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population aged over 18 years with esophagectomy for cancer
Key inclusion criteria (2 listed)
- Esophagectomy for cancer
- written and oral agreement
Key exclusion criteria (4 listed)
- pregnant women,
- patients with permanent atrial fibrillation,
- patients with pace-maker
- Patients under guardianship/curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Holter ECGMeasurement of the modification of the sympathomimetic balance | Diagnostic test | – |
| QuestionaryLifestyle questionary (time spent in front of television, physical activity) | Behavioural | – |
| PupillometryMonitoring of nociception and autonomic nervous system by pupillometry in intraoperative. | Diagnostic test | – |
Primary outcome
Analysis of Standard deviation of all NN (SDNN) (ms)
Time frame: before surgery
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
Analysis of Standard deviation of all NN (SDNN) (ms)
Time frame: day 7 to day 90
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
10 secondary outcomes
HF activity
Time frame: before surgery : Day -82, Day -30, Day -1
LF activity
Time frame: before surgery : Day -82, Day -30, Day -1
LF/HF ratio
Time frame: before surgery : Day -82, Day -30, Day -1
HF activity
Time frame: after surgery : day 7, day 60, day 90
LF activity
Time frame: after surgery : day 7, day 60, day 90
LF/HF ratio
Time frame: after surgery : day 7, day 60, day 90
change in baroreflex
Time frame: Day -1, Day 7, day discharge, day 90
modify the respiratory functional exploration
Time frame: Day -30, Day 30, Day 60
intraoperative pupillometry
Time frame: during surgery
physical capacity
Time frame: Day-30, Day 30, Day 90
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EVE HUART, MD principal investigator
CHU ST ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Standard deviation of all NN (SDNN) (ms) (time frame: before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.