Nerve Stimulation During Esophagectomy

NCT04171011 | Completed

• 1 other identifier: GAL1018
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Response

Outcome Measures

Primary Outcomes (2)

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

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

  1 day

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

  Incidence of adverse events

  7 days

Secondary Outcomes (3)

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

  Before stimulation and during stimulation

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

  Before stimulation and during stimulation

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

  Before stimulation and during stimulation

Other Outcomes (10)

• Heart Rate (HR) change

  Before stimulation and during stimulation

• Systolic Blood Pressure (SBP) change

  Before stimulation and during stimulation

• Diastolic Blood Pressure (DBP) change

  Before stimulation and during stimulation

Study Arms (1)

Nerve Stimulation

EXPERIMENTAL

Participants will undergo brief NVB stimulation during the esophagectomy procedure.

Device: Stimulator device

Interventions

Stimulator device DEVICE

The stimulator device will be used to electrically stimulate the NVB

Nerve Stimulation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous splenectomy
• Existing implantable device
• Active pancreatitis or history of severe pancreatitis with complications, hepatic or splenic disease
• 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

Sponsors & Collaborators

• Galvani Bioelectronics: lead
• NAMSA: collaborator

Study Sites (1)

Catharina Ziekenhuis

Eindhoven, Netherlands

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 20, 2019
• Study Start: November 28, 2019
• Primary Completion: October 6, 2020
• Study Completion: October 6, 2020
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

NL (1)