Intraoperative ICG for Systemic Sclerosis

Systemic Sclerosis Clinical Trial

Official title:

A Prospective Study of the Utility of Intraoperative, Quantitative Indocyanine Green Angiography in Microvascular Surgery for Systemic Scerlosis

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03155464
• Other study ID #: Pro00078686
• Status: Withdrawn
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: January 23, 2018

Study information

• Verified date: June 2020
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate the relative intraoperative improvement in perfusion between arterial reconstruction and sympathectomies with quantitative ICG. A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a one to one randomized study design. There is the potential risk of loss of confidentiality. The study involves the intraoperative assessment of perfusion by quantitative ICG. ICG is FDA approved for this usage and will be used according to its labeling. Assessment involves intraoperative quantitative ICG data, questionnaires, and patient and physician assessments. There are no additional physical risks associated with participating in this study over and above that of the planned arterial reconstruction (bypass) and sympathectomies.The information collected will be kept confidential and will comply with the HIPAA.

Description:

A minimum of 40 patients, 20 Sympathectomy Prior to Bypass (group 1) and 20 Bypass Prior to Sympathectomy (group 2), will be recruited for this study. This study will enroll participants in a 1:1 randomized study design. Participants will serve as their own controls. A consecutive series of patients will be randomized to either Group 1 or 2. Randomization will occur through 40 sealed, opaque sequentially numbered envelopes containing the randomization. Those that qualify and sign consent will be randomized 24hrs prior to surgery. The randomization envelopes will be stored in a locked filing cabinet within the clinical research coordinators office. The subject will know what treatment arm they are in prior to surgery.

Patients will be randomized to Group 1 or 2. If patients are randomized to Group 1, patients will receive sympathectomy prior to bypass during the surgical procedure (see below). If patients are randomized to Group 2, they will received bypass prior to sympathectomy during the surgical procedure (see below). Patients in both groups will be in the study for the next 12 months. Normal clinical practice will not change. Patients in both groups will be examined before surgery. If they provide consent to participate, demographical data, comorbidities, the number and severity of digital ulcerations, and baseline outcome measures for the Michigan Hand Outcome Questionnaire, Disabilities of the Arm, Shoulder and Hand and the Visual Analogue Scale for Pain will be collected.

Patients in both groups will return to the office for routine follow-up at 2 weeks for wound care. The next study visit will occur at 6 weeks. At that time, outcome measures will be again administered and data collected. In accordance with standard clinical practice, the patients will return to the office for examination again at 6 months and 1 year. At these times, the primary clinical outcomes will be collected as well as the patient reported outcomes.

These are normal visits, not outside the scope of routine clinical practice. Intraoperative ICG is also within the scope of routine clinical practice. The dose of ICG and the number of times that it is administered to subjects is the same as in standard of care.

ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. The laser diode array utilized by the SPY System emits a near-infrared wavelength that does not require the use of protective eyewear or other safety equipment. The investigators will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. Of note, No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 23, 2018
• Est. primary completion date: January 23, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• o Patient has signed an IRB approved, study specific Informed Patient Consent Form.

• Patient is a male or non-pregnant female age 18 - 85 years at time of study enrollment.

• Patient has a diagnosis of a systemic sclerosis with vascular obstruction of the hand resulting in digital ischemia, ulceration, and/or gangrene and have failed nonoperative treatments.

• Patient is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion Criteria:

• • Patient is undergoing revision surgery.

• Patient has a diagnosis of avascular necrosis or inflammatory arthritis.

• If, during surgery, the arterial reconstruction could not be performed because the vessel was damaged to the point where there was no appropriate site for a bypass anastomosis.

• Patient is a prisoner

• Pregnant women confirmed by testing prior to surgery, and nursing mothers

• Patient has an allergy to iodine confirmed during initial history and on day of surgery

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Procedure:
• Order of two elements of surgical procedure
Please see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2.

Drug:
• Indocyanine Green
Intraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Comparison of clinical and intraoperative quantitative ICG measurements	Correlation of primary clinical measures with results of intraoperative quantitative ICG at 1 year postoperative	Baseline-One Year Follow-up
Other	Change in Michigan Hand Outcome Questionnaire	Change in Michigan Hand Outcome Questionnaire	Baseline-One Year Follow-up
Other	Change in Visual Analogue Scale for Pain (VAS)	Change in Visual Analogue Scale for Pain (VAS); patient reported level of pain which is then measured (distance from 0 in mm)	Baseline-One Year Follow-up
Other	Change in Disability of the Arm, Shoulder, and Hand Questionnaire (DASH)	Change in DASH score; scale of 0-100. 30 questions in total with optional work and optional sports/activities questions (with 4 questions each)	Baseline-One Year Follow-up
Other	Complete healing of all ulcers	Complete healing of all ulcers (yes/no)	1 Year Follow-up
Other	Number of all ulcers	Number of all ulcers	1 Year Follow-up
Other	Need for amputation by the end of one-year follow-up	Need for amputation by the end of one-year follow-up (yes/no)	1-year follow-up
Primary	Change in perfusion	To compare the relative intraoperative change in perfusion between arterial reconstruction and sympathectomies with quantitative ICG.	Baseline-One Year Follow-up
Secondary	Intraoperative change in hand and digit perfusion	To document the immediate intraoperative quantitative change in hand and digit perfusion in combined arterial reconstruction and sympathectomies in patients with systemic sclerosis using intraoperative quantitative ICG.	Baseline-One Year Follow-up