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Nerve Stimulation During Esophagectomy

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ClinicalTrials.gov Identifier: NCT04171011
Recruitment Status : Completed
First Posted : November 20, 2019
Last Update Posted : October 29, 2020
Sponsor:
Collaborator:
NAMSA
Information provided by (Responsible Party):
Galvani Bioelectronics

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Inflammatory Response Device: Stimulator device Not Applicable

Detailed Description:

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Feasibility of Splenic Nerve Stimulation During Esophagectomy
Actual Study Start Date : November 28, 2019
Actual Primary Completion Date : October 6, 2020
Actual Study Completion Date : October 6, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Nerve Stimulation
Participants will undergo brief NVB stimulation during the esophagectomy procedure.
 Device: Stimulator device
The stimulator device will be used to electrically stimulate the NVB


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04171011


Locations
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Netherlands
Catharina Ziekenhuis
Eindhoven, Netherlands
Sponsors and Collaborators
Galvani Bioelectronics
NAMSA
More Information
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Responsible Party: Galvani Bioelectronics
ClinicalTrials.gov Identifier: NCT04171011    
Other Study ID Numbers: GAL1018
First Posted: November 20, 2019    Key Record Dates
Last Update Posted: October 29, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No