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Esophageal CancerNCT03021200

Laser Fluorescence in Cancer Surgical Treatment

A study testing Green indocianine in people with Esophageal Cancer and Gastric Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Green indocianine
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteBrazil
Study dates
12 Jul 2016to 10 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site, 1 recruiting
  • Ulysses Ribeiro Junior

    São Paulo, São Paulo, 01246-000

    Evelise P Zaidan, 55 11 38933546, evelise.zaidan@hc.usp.br

    Marcus FKP Ramos, MD

    Recruiting

Other trials in Brazil

About this study

Official title: Use of Laser Fluorescence With Spy Elite, Pinpoint and Firefly Robotic Platform Systems in Cancer Surgical Treatment

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.

Read more

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

Being tested
Green indocianine
Medical subject headings
Esophageal Neoplasms, Stomach Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Uterine Neoplasms, Head and Neck Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Green indocianineDevice

    Laser fluorescence using green indocianine guiding the surgical procedure.

Study groups in NCT03021200
Study groupRoleWhat they receive
Indocyanine green in Conventional Oncological SurgeryExperimentalUse of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries
Receives: Device: Green indocianine
Indocyanine green in minimally invasive Oncological SurgeryExperimentalUse of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Pinpoint) for minimally invasive oncological surgeries
Receives: Device: Green indocianine
Indocyanine green in robot-assisted Oncological SurgeryExperimentalUse of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Firefly) for robot-assisted oncological surgeries
Receives: Device: Green indocianine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intestinal Anastomosis Fistula

    Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors

    Measured: 3 years

  2. Esophageal fistula

    Esophageal reconstruction fistula rate in esophagectomies

    Measured: 3 years

  3. positive lymph nodes

    The number of fluorescence-positive lymph nodes per patient

    Measured: 3 years

  4. lymph nodes detected by pathology

    The number of lymph nodes detected by pathology per patient

    Measured: 3 years

  5. Mastectomy Skin Necrosis

    Mastectomy Skin Necrosis Rate in Breast Reconstructions

    Measured: 3 years

  6. Breast Implant Extrusion

    Breast Implant Extrusion Rate in Breast Reconstructions

    Measured: 3 years

  7. Surgical Site Infection in Breast Reconstructions

    Surgical Site Infection Rate in Breast Reconstructions

    Measured: 3 years

  8. Skin Necrosis in Head and Neck Reconstruction

    Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2017 (estimated)
  2. Study start12 Jul 2016
  3. Primary completion12 Oct 2017
  4. Study completion10 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03021200
Sponsor's protocol ID
NP953/16
Status last verified
Nov 2019
First submitted
4 Jan 2017
Last updated
12 Nov 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Green indocianine in people with Esophageal Cancer and Gastric Cancer, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ulysses Ribeiro, MD (55 11 3893-2574, ulysses.ribeiro@fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intestinal Anastomosis Fistula (time frame: 3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019.

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