Nerve Stimulation During Esophagectomy

Not Applicable

Completed

• Conditions: Inflammatory Response
• Interventions: Device: Stimulator device

• Registration Number: NCT04171011
• Lead Sponsor: Galvani Bioelectronics

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.

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 Timeline

• Study First Submitted: 2019-11-18
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-20
• Study Start: 2019-11-28
• Status Verified: 2020-10
• Primary Completion: 2020-10-06
• Study Completion: 2020-10-06
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nerve Stimulation	Stimulator device	Participants will undergo brief NVB stimulation during the esophagectomy procedure.

Primary Outcome Measures

Name	Time	Method
Safety of placement, stimulation and removal of the lead: Incidence of adverse events	7 days	Incidence of adverse events
Feasibility applying and removing the stimulation lead: Proportion of participants in whom the lead was successfully applied and removed	1 day	Proportion of participants in whom the lead was successfully applied and removed

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands