Optical Detection of Peripheral Nerve Bundles During Surgery

Completed

• Conditions: Colon Rectal Cancer Tubulovillous Adenocarcinoma; Malignant Lymphoma of Lymph Nodes of Axillary; Malignant Lymphoma of Lymph Nodes of Inguinal Region; Malignant Lymphoma of Lymph Nodes of the Cervix; Carcinoma of Parotid Gland; Tumor of Soft Tissue of Head, Face and Neck
• Interventions: Procedure: Surgical resection

• Registration Number: NCT01731379
• Lead Sponsor: Philips Healthcare

Brief Summary

Investigation of application possibilities of optical spectroscopy within the field of surgical resection procedures to spare nerve tissue. Optical spectroscopy enables the possibility to specifically differentiate between different (human) tissues. The hypothesis is that incorporation of this technique into existing medical devices (e.g. medical blade) would enlarge the accuracy and reliability of these devices. Sparing of nerve bundles during surgery can lead to decreased postoperative morbidity rates.

Detailed Description

The aim of this pilot study is to prove that an investigational optical spectroscopy system can provide accurate identification of nerve tissue during surgery.

Primary Objective:

The goal of this pilot study is to evaluate whether optical spectroscopy is able to differentiate between nerve tissue and surrounding tissue.

Secondary Objective:

During the measurement procedure, possible improvements of the measurement hardware will be recorded and the handling of the optical spectroscopy system during surgery will be evaluated.

Study Timeline

• Study First Submitted: 2012-11-16
• Study First Submitted QC: 2012-11-16
• Study First Posted: 2012-11-21
• Study Start: 2012-12
• Primary Completion: 2014-01
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
• Patients that have provided a signed informed consent
• Patients ≥ 18 years old

Exclusion Criteria

• Patients with suspected sensitivity to light; e.g. patients who have had photodynamic therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Surgical resections	Surgical resection	Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy, patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

Primary Outcome Measures

Name	Time	Method
Differentiation between nerve tissue and its surrounding tissue	Day 0	Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations

Trial Locations

Locations (1)

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis; 🇳🇱 Amsterdam, Noord-Holland, Netherlands