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Nerve Stimulation During Esophagectomy

NCT ID: NCT04171011

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-28

Study Completion Date

2020-10-06

Brief Summary

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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

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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).

Conditions

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Inflammatory Response

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Nerve Stimulation

Participants will undergo brief NVB stimulation during the esophagectomy procedure.

Group Type EXPERIMENTAL

Stimulator device

Intervention Type DEVICE

The stimulator device will be used to electrically stimulate the NVB

Interventions

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Stimulator device

The stimulator device will be used to electrically stimulate the NVB

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NAMSA

OTHER

Sponsor Role collaborator

Galvani Bioelectronics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Catharina Ziekenhuis

Eindhoven, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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GAL1018

Identifier Type: -

Identifier Source: org_study_id