Clinical trial · Observational
Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer
Prospective Monocentric Evaluation of the Autonomic Nervous System in Patients Undergoing Esophagectomy for Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to a lack of staff in the department, no inclusion could be realized.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Holter ECG | Diagnostic Test | — | UNRESOLVED |
| Pupillometry | Diagnostic Test | — | UNRESOLVED |
| Questionary | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Analysis of Standard deviation of all NN (SDNN) (ms)
- timeFrame
- before surgery
- description
- 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
- measure
- Analysis of Standard deviation of all NN (SDNN) (ms)
- timeFrame
- day 7 to day 90
- description
- 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
Secondary outcomes (10)
- measure
- HF activity
- timeFrame
- before surgery : Day -82, Day -30, Day -1
- description
- Day 0 = surgery measured with the Holter Electrocardiogram
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available