Nerve Stimulation During Esophagectomy

Inflammatory Response Clinical Trial

Official title:

Feasibility of Splenic Nerve Stimulation During Esophagectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04171011
• Other study ID #: GAL1018
• Status: Completed
• Phase: N/A
• Start date: November 28, 2019
• Est. completion date: October 6, 2020

Study information

• Verified date: October 2020
• Source: Galvani Bioelectronics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 6, 2020
• Est. primary completion date: October 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Response

Intervention

Device:
• Stimulator device
The stimulator device will be used to electrically stimulate the NVB

Locations

Country	Name	City	State
Netherlands	Catharina Ziekenhuis	Eindhoven

Sponsors (2)

Lead Sponsor	Collaborator
Galvani Bioelectronics	NAMSA

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate (HR) change		Before stimulation and during stimulation
Other	Systolic Blood Pressure (SBP) change		Before stimulation and during stimulation
Other	Diastolic Blood Pressure (DBP) change		Before stimulation and during stimulation
Other	Mean Arterial Blood Pressure (MAP) change		Before stimulation and during stimulation
Other	Hematology (white blood cell (WBC) counts)		Before stimulation to Day 1 post stimulation
Other	Cytokine IL-6		Before stimulation to Day 1 post stimulation
Other	Cytokine IL-8		Before stimulation to Day 1 post stimulation
Other	Cytokine IL-10		Before stimulation to Day 1 post stimulation
Other	Cytokine TNF		Before stimulation to Day 1 post stimulation
Other	C-Reactive Protein level		At days 2 and 3 post stimulation
Primary	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
Primary	Safety of placement, stimulation and removal of the lead: Incidence of adverse events	Incidence of adverse events	7 days
Secondary	Peak Systolic Velocity (PSV) blood flow change measured by doppler ultrasound		Before stimulation and during stimulation
Secondary	End Diastolic Velocity (EDV) blood flow change measured by doppler ultrasound		Before stimulation and during stimulation
Secondary	Velocity Time Integral (VTI) blood flow change measured by doppler ultrasound		Before stimulation and during stimulation