Optical Detection of Peripheral Nerve Bundles During Surgery

NCT01731379 | Completed DMC

• 1 other identifier: NL 40893.031.12
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Lymphoma of Lymph Nodes of Inguinal Region; Malignant Lymphoma of Lymph Nodes of Axillary; Malignant Lymphoma of Lymph Nodes of the Cervix; Carcinoma of Parotid Gland; Colon Rectal Cancer Tubulovillous Adenocarcinoma; Tumor of Soft Tissue of Head, Face and Neck

Keywords

spectroscopy; nerve; muscle; fat

Outcome Measures

Primary Outcomes (1)

• Differentiation between nerve tissue and its surrounding tissue

  Statistical analysis of the difference between diffuse reflectance spectra obtained at nerve tissue and its surrounding tissue measurement locations

  Day 0

Study Arms (1)

Surgical resections

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.

Procedure: Surgical resection

Interventions

Surgical resection PROCEDURE

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.

Also known as: lymph node dissection, resection of parotid gland, rectal surgery, soft tumor resection

Surgical resections

Eligibility Criteria

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

Study Population

Eligible patients are patients of the Netherlands Cancer Institute (NKI-AvL), who are scheduled for an elective inguinal, axillary or cervical lymph node dissection, or parotidectomy as well as patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Philips Healthcare: lead
• Philips Electronics Nederland B.V. acting through Philips CTO organization: collaborator

Study Sites (1)

Nederlands Kanker Instituut/Antonie van Leeuwenhoek Ziekenhuis

Amsterdam, North Holland, 1066 CX, Netherlands

Location

MeSH Terms

Conditions

Parotid Neoplasms; Facies; Platelet Glycoprotein IV Deficiency

Interventions

Lymph Node Excision

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Parotid Diseases; Salivary Gland Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Theo Ruers, MD

  Nederlands Kanker Instituut/Antonie van leeuwenhoek Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 21, 2012
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: October 1, 2015
• Last Updated: November 3, 2015

Record last verified: 2015-11

Locations

NL (1)