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Laser Fluorescence in Cancer Surgical Treatment

Primary Purpose

Esophageal Cancer, Gastric Cancer, ColoRectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Green indocianine
Sponsored by
Instituto do Cancer do Estado de São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • Ulysses Ribeiro JuniorRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Indocyanine green in Conventional Oncological Surgery

Indocyanine green in minimally invasive Oncological Surgery

Indocyanine green in robot-assisted Oncological Surgery

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Intestinal Anastomosis Fistula
Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors
Esophageal fistula
Esophageal reconstruction fistula rate in esophagectomies
positive lymph nodes
The number of fluorescence-positive lymph nodes per patient
lymph nodes detected by pathology
The number of lymph nodes detected by pathology per patient
Mastectomy Skin Necrosis
Mastectomy Skin Necrosis Rate in Breast Reconstructions
Breast Implant Extrusion
Breast Implant Extrusion Rate in Breast Reconstructions
Surgical Site Infection in Breast Reconstructions
Surgical Site Infection Rate in Breast Reconstructions
Skin Necrosis in Head and Neck Reconstruction
Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction

Secondary Outcome Measures

Full Information

First Posted
January 4, 2017
Last Updated
November 8, 2019
Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Ministry of Health, Brazil, Fundação Faculdade de Medicina
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1. Study Identification

Unique Protocol Identification Number
NCT03021200
Brief Title
Laser Fluorescence in Cancer Surgical Treatment
Official Title
Use of Laser Fluorescence With Spy Elite, Pinpoint and Firefly Robotic Platform Systems in Cancer Surgical Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 12, 2016 (Actual)
Primary Completion Date
October 12, 2017 (Actual)
Study Completion Date
December 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
Collaborators
Ministry of Health, Brazil, Fundação Faculdade de Medicina

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastric Cancer, ColoRectal Cancer, Prostatic Neoplasms, Uterine Cancer, Head and Neck Cancer, Breast Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Indocyanine green in Conventional Oncological Surgery
Arm Type
Experimental
Arm Description
Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries
Arm Title
Indocyanine green in minimally invasive Oncological Surgery
Arm Type
Experimental
Arm Description
Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Pinpoint) for minimally invasive oncological surgeries
Arm Title
Indocyanine green in robot-assisted Oncological Surgery
Arm Type
Experimental
Arm Description
Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Firefly) for robot-assisted oncological surgeries
Intervention Type
Device
Intervention Name(s)
Green indocianine
Intervention Description
Laser fluorescence using green indocianine guiding the surgical procedure.
Primary Outcome Measure Information:
Title
Intestinal Anastomosis Fistula
Description
Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors
Time Frame
3 years
Title
Esophageal fistula
Description
Esophageal reconstruction fistula rate in esophagectomies
Time Frame
3 years
Title
positive lymph nodes
Description
The number of fluorescence-positive lymph nodes per patient
Time Frame
3 years
Title
lymph nodes detected by pathology
Description
The number of lymph nodes detected by pathology per patient
Time Frame
3 years
Title
Mastectomy Skin Necrosis
Description
Mastectomy Skin Necrosis Rate in Breast Reconstructions
Time Frame
3 years
Title
Breast Implant Extrusion
Description
Breast Implant Extrusion Rate in Breast Reconstructions
Time Frame
3 years
Title
Surgical Site Infection in Breast Reconstructions
Description
Surgical Site Infection Rate in Breast Reconstructions
Time Frame
3 years
Title
Skin Necrosis in Head and Neck Reconstruction
Description
Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with a history of adverse reaction or known allergy to contrast, or iodine tinctures; Pregnant or lactating women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ulysses Ribeiro, MD
Phone
55 11 3893-2574
Email
ulysses.ribeiro@fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Evelise P Zaidan
Phone
55 11 3893-3546
Email
evelize.zaidan@hc.fm.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulysses Ribeiro, MD
Organizational Affiliation
Instituto do Cancer do Estado de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulysses Ribeiro Junior
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelise P Zaidan
Phone
55 11 38933546
Email
evelise.zaidan@hc.usp.br
First Name & Middle Initial & Last Name & Degree
Marcus FKP Ramos, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Laser Fluorescence in Cancer Surgical Treatment

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