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Completed

NCT Number: NCT04171011

Nerve Stimulation During Esophagectomy

Esophagectomy is the cornerstone for treatment of esophageal cancer. However, it is associated with substantial morbidity and mortality. Studies suggest that systemic inflammation after surgery has a negative impact on surgical outcomes. Attenuation of an excessive inflammatory response within the perioperative period for high-risk surgical procedures may reduce morbidity and mortality. The inflammatory response may be important in the development of these complications and reduction of inflammatory cytokine may be associated with an improved outcome.

The current study will evaluate the feasibility and safety of neuromodulation during minimally invasive surgery for esophageal cancer (esophagectomy) to assess impact on the inflammatory response. During the esophagectomy, a stimulation lead will be placed on the exposed nerves, and energy applied to the lead to test whether the nerves can be activated. The study will also measure potential physiological responses to nerve activation.

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Key information

Conditions

Inflammatory Response

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Catharina Ziekenhuis

Eindhoven, Netherlands

About this study

Active dampening of the inflammatory response may be an important therapeutic target to decrease complications and improve recovery following esophagectomy. The current study is intended to evaluate the feasibility and safety of stimulating the exposed nerves in esophagectomy patients.

During minimally invasive esophagectomy, a neurovascular bundle (NVB) is exposed or partially exposed as part of the obligatory lymph node dissection. At the point in the esophagectomy when the NVB is being isolated, a lead will be applied laparoscopically to the NVB and connected to an external pulse generator. An ultrasound transducer will be introduced to the abdomen and placed on the NVB to visualize splenic arterial blood flow. The NVB will be stimulated while physiologic responses are observed. Blood samples will be taken before, and at certain pre-defined time points after, stimulation and recovery. The lead and ultrasound transducer will be removed after completion of stimulation, and the esophagectomy surgery will continue. Surgeon experience applying and removing the cuff electrode will be documented, in addition to the responses to NVB stimulation. Post-operative safety will be followed through 7-days (or day of discharge if earlier).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female of non-reproductive potential or male
  • Undergoing minimally invasive esophagectomy
  • Confirmed presence of splenic NVB loop via imaging prior to surgery
  • Age equal or above 21 years at the screening visit
  • Capable of giving signed informed consent (IC)
  • Normal blood pressure, or hypertensive managed with medication such that they are deemed fit for surgery

Exclusion criteria

  • Previous splenectomy
  • Existing implantable device
  • Active pancreatitis or history of severe pancreatitis with complications, hepatic or splenic disease
  • Use of oral steroids 4 weeks prior to inclusion
  • Current use immunosuppressive agents or biologicals. Previous use of biologicals is allowed, if a washout period of 2 months is applied
  • Use of anticoagulants within 1 week of surgery

Treatment and study plan

Stimulator device

Device

The stimulator device will be used to electrically stimulate the NVB

Primary outcomes

  1. Feasibility applying and removing the stimulation lead: Proportion of participants in whom the lead was successfully applied and removed

    Time frame: 1 day

    Proportion of participants in whom the lead was successfully applied and removed

  2. Safety of placement, stimulation and removal of the lead: Incidence of adverse events

    Time frame: 7 days

    Incidence of adverse events

Secondary outcomes

  1. Peak Systolic Velocity (PSV) blood flow change measured by doppler ultrasound

    Time frame: Before stimulation and during stimulation

  2. End Diastolic Velocity (EDV) blood flow change measured by doppler ultrasound

    Time frame: Before stimulation and during stimulation

  3. Velocity Time Integral (VTI) blood flow change measured by doppler ultrasound

    Time frame: Before stimulation and during stimulation

Other outcomes

  1. Heart Rate (HR) change

    Time frame: Before stimulation and during stimulation

  2. Systolic Blood Pressure (SBP) change

    Time frame: Before stimulation and during stimulation

  3. Diastolic Blood Pressure (DBP) change

    Time frame: Before stimulation and during stimulation

  4. Mean Arterial Blood Pressure (MAP) change

    Time frame: Before stimulation and during stimulation

  5. Hematology (white blood cell (WBC) counts)

    Time frame: Before stimulation to Day 1 post stimulation

  6. Cytokine IL-6

    Time frame: Before stimulation to Day 1 post stimulation

  7. Cytokine IL-8

    Time frame: Before stimulation to Day 1 post stimulation

  8. Cytokine IL-10

    Time frame: Before stimulation to Day 1 post stimulation

  9. Cytokine TNF

    Time frame: Before stimulation to Day 1 post stimulation

  10. C-Reactive Protein level

    Time frame: At days 2 and 3 post stimulation

Sponsors and collaborators

Lead sponsor

Galvani Bioelectronics

Industry

Collaborators

  • NAMSA

Registry information

Official study title

Feasibility of Splenic Nerve Stimulation During Esophagectomy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 20, 2019
Registry last updated
Oct 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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