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.
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
- Conditions the study is for
- Esophageal Cancer, Gastric Cancer, ColoRectal Cancer
- 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
- 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
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
- Conditions
- Esophageal Cancer, Gastric Cancer, ColoRectal Cancer, Prostatic Neoplasms, Uterine Cancer, Head and Neck Cancer
- 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 group | Role | What they receive |
|---|---|---|
| Indocyanine green in Conventional Oncological Surgery | Experimental | Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries Receives: 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 Receives: 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 Receives: Device: Green indocianine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intestinal Anastomosis Fistula
Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors
Measured: 3 years
Esophageal fistula
Esophageal reconstruction fistula rate in esophagectomies
Measured: 3 years
positive lymph nodes
The number of fluorescence-positive lymph nodes per patient
Measured: 3 years
lymph nodes detected by pathology
The number of lymph nodes detected by pathology per patient
Measured: 3 years
Mastectomy Skin Necrosis
Mastectomy Skin Necrosis Rate in Breast Reconstructions
Measured: 3 years
Breast Implant Extrusion
Breast Implant Extrusion Rate in Breast Reconstructions
Measured: 3 years
Surgical Site Infection in Breast Reconstructions
Surgical Site Infection Rate in Breast Reconstructions
Measured: 3 years
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.
- First posted13 Jan 2017 (estimated)
- Study start12 Jul 2016
- Primary completion12 Oct 2017
- Study completion10 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Brazil, Fundação Faculdade de Medicina
- Responsible party
- Sponsor
- Investigators
- Ulysses Ribeiro, MD, Principal investigator, Instituto do Cancer do Estado de Sao Paulo
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Laser Fluorescence With Spy Elite, Pinpoint and Firefly Robotic Platform Systems in Cancer Surgical Treatment
- ClinicalTrials.gov ID
- NCT03021200
- Acronym / sponsor ID
- NP953/16
- Conditions
- Esophageal Cancer, Gastric Cancer, ColoRectal Cancer, Prostatic Neoplasms, Uterine Cancer, Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Ministry of Health, Brazil, Fundação Faculdade de Medicina
- Study start
- 12 Jul 2016 (actual)
- Primary completion
- 12 Oct 2017 (actual)
- Study completion
- 10 Dec 2020 (estimated)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Indocyanine green in Conventional Oncological Surgery | Experimental | Device: Green indocianineUse of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries |
| Indocyanine green in minimally invasive Oncological Surgery | Experimental | Device: Green indocianineUse of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Pinpoint) for minimally invasive oncological surgeries |
| Indocyanine green in robot-assisted Oncological Surgery | Experimental | Device: Green indocianineUse of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Firefly) for robot-assisted oncological surgeries |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with cancer and indication for one of the following surgeries:
- Low Anterior Resection
- Esophagectomy
- Lymphadenectomy
- Prostatectomy
Key exclusion criteria (2 listed)
- Patients with a history of adverse reaction or known allergy to contrast, or iodine tinctures;
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Green indocianineLaser fluorescence using green indocianine guiding the surgical procedure. | Device | Indocyanine green in Conventional Oncological Surgery, Indocyanine green in minimally invasive Oncological Surgery, Indocyanine green in robot-assisted Oncological Surgery |
Primary outcome
Intestinal Anastomosis Fistula
Time frame: 3 years
Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors
Esophageal fistula
Time frame: 3 years
Esophageal reconstruction fistula rate in esophagectomies
positive lymph nodes
Time frame: 3 years
The number of fluorescence-positive lymph nodes per patient
lymph nodes detected by pathology
Time frame: 3 years
The number of lymph nodes detected by pathology per patient
Mastectomy Skin Necrosis
Time frame: 3 years
Mastectomy Skin Necrosis Rate in Breast Reconstructions
Breast Implant Extrusion
Time frame: 3 years
Breast Implant Extrusion Rate in Breast Reconstructions
Surgical Site Infection in Breast Reconstructions
Time frame: 3 years
Surgical Site Infection Rate in Breast Reconstructions
Skin Necrosis in Head and Neck Reconstruction
Time frame: 3 years
Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Individual participant dataSharing planned: No
Related trials for Esophageal Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08046876 in People With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulysses Ribeiro, MD principal investigator
Instituto do Cancer do Estado de Sao Paulo
1 site in 1 country: see every site and its status.
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.