Laser Fluorescence in Cancer Surgical Treatment

NCT03021200 | Unknown DMC

• 1 other identifier: NP953/16
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

The use of fluorescence for real-time evaluation of organ and tissue vascularization and lymph node anatomy is a recent technology with potential for the surgical treatment of cancer. The real-time analysis of tissue vascularization allows immediate identification to the surgeon of areas with greater or lesser blood circulation, favoring surgical decision making and prevention of complications related to tissue ischemia (necrosis, dehiscences and infections). It is a technology with potential application in the areas of Digestive Surgery, Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition, fluorescence can be used as a method to identify lymph node structures of interest in the oncological treatment of patients with urologic, gynecological and digestive tumors. Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp., Branchburg, N.J.) had its initial application in repairing surgery after breast cancer treatment. The method proved to be useful in the prevention of ischemic and infectious complications in cancer surgery. Pestana, in a prospective clinical series of 29 microsurgical flaps used in several reconstructions, observed a single case of partial loss of the flap, the present technology having a relevant role in intraoperative decision making. In the same year, Newman et al. The first application of the system in breast reconstruction surgery. In an initial series of 10 consecutive cases of reconstruction with microsurgical flaps, in 4 cases the system allowed the intraoperative identification of areas of low perfusion, thus changing the surgical procedure. According to the authors, there was a 95% correlation between indocyanine laser assisted and subsequent development of mastectomy skin necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray et al. Evaluated the intraoperative perfusion, however, of the areola-papillary complex in patients submitted to subcutaneous mastectomies with satisfactory results in terms of predictability of cutaneous circulation. Other authors in larger clinical series and evaluating other procedures have observed valid results in terms of prevention of complications. Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a serious and common complication. These fistulas can be caused by insufficient perfusion of the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can be used to visualize the blood perfusion following intravenous injection of the indocyanine green contrast. Several groups reported the ability to assess blood perfusion of the anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and colleagues described a reduction in the risk of revision due to fistula in 60% of patients whose anastomosis was examined using laser fluorescence angiography compared to historically paired patients without this method. The same principle can be used to evaluate the tubulized stomach to be transposed to the cervical region after subtotal esophagectomy. Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer as well as investigative character in colorectal cancer, skin cancer, cervical cancer, vulvar cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric cancer and esophageal cancer. These early studies demonstrated the feasibility of this methodology during surgery. Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can replace blue dyes because they exceed them due to increased tissue penetration depth and absence of staining in the patient and cleaning of the operative field. To date, there are no clinical studies involving intraoperative perfusion mapping and identification of lymph node structures with the SPY Elite System © system or other platforms (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an objective way the influence of this technology as predictive in the better or worse evolution of the oncologic surgery as well as in the prevention of the local ischemic complications by means of intraopeal change of conduct

Conditions

Esophageal Cancer; Gastric Cancer; ColoRectal Cancer; Prostatic Neoplasms; Uterine Cancer; Head and Neck Cancer; Breast Neoplasm

Outcome Measures

Primary Outcomes (8)

• Intestinal Anastomosis Fistula

  Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors

  3 years

• Esophageal fistula

  Esophageal reconstruction fistula rate in esophagectomies

  3 years

• positive lymph nodes

  The number of fluorescence-positive lymph nodes per patient

  3 years

• lymph nodes detected by pathology

  The number of lymph nodes detected by pathology per patient

  3 years

• Mastectomy Skin Necrosis

  Mastectomy Skin Necrosis Rate in Breast Reconstructions

  3 years

• Breast Implant Extrusion

  Breast Implant Extrusion Rate in Breast Reconstructions

  3 years

• Surgical Site Infection in Breast Reconstructions

  Surgical Site Infection Rate in Breast Reconstructions

  3 years

• Skin Necrosis in Head and Neck Reconstruction

  Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction

  3 years

Study Arms (3)

Indocyanine green in Conventional Oncological Surgery

EXPERIMENTAL

Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries

Device: Green indocianine

Indocyanine green in minimally invasive Oncological Surgery

EXPERIMENTAL

Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Pinpoint) for minimally invasive oncological surgeries

Device: Green indocianine

Indocyanine green in robot-assisted Oncological Surgery

EXPERIMENTAL

Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Firefly) for robot-assisted oncological surgeries

Device: Green indocianine

Interventions

Green indocianine DEVICE

Laser fluorescence using green indocianine guiding the surgical procedure.

Indocyanine green in Conventional Oncological Surgery; Indocyanine green in minimally invasive Oncological Surgery; Indocyanine green in robot-assisted Oncological Surgery

Eligibility Criteria

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

You may qualify if:

• Patients with cancer and indication for one of the following surgeries:
• Low Anterior Resection
• Esophagectomy
• Lymphadenectomy
• Prostatectomy
• Pelvic or paraortic lymphadenectomy
• Surgery of head and neck with indication of supraclavicular flap
• Mastectomy followed by immediate or late breast reconstruction

You may not qualify if:

• Patients with a history of adverse reaction or known allergy to contrast, or iodine tinctures;
• Pregnant or lactating women.

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Ministry of Health, Brazil: collaborator
• Fundação Faculdade de Medicina: collaborator

Study Sites (1)

Ulysses Ribeiro Junior

São Paulo, São Paulo, 01246-000, Brazil

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Prostatic Neoplasms; Uterine Neoplasms; Head and Neck Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Genital Neoplasms, Female; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ulysses Ribeiro, MD

  Instituto do Cancer do Estado de Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ulysses Ribeiro, MD

CONTACT

55 11 3893-2574; ulysses.ribeiro@fm.usp.br

Evelise P Zaidan

CONTACT

55 11 3893-3546; evelize.zaidan@hc.fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 13, 2017
• Study Start: July 12, 2016
• Primary Completion: October 12, 2017
• Study Completion: December 10, 2020
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)