A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

Study Overview
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Brief Summary
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This is a randomized, controlled, parallel, multicenter study to determine the difference in post-operative anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone.

Official Title
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A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

Conditions
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Rectal Cancer, Rectosigmoid Cancer

Intervention / Treatment
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* Device: PINPOINT
* Device: SPY Elite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years of age or older. Be undergoing open, or minimally invasive LAR for the treatment of a rectal or rectosigmoid neoplasm (Subjects with rectal or rectosigmoid neoplasm(s) may be treated with or without neoadjuvant therapy. Long-course neoadjuvant therapy must have been completed ≥6 weeks prior to LAR surgery (Day 0). Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from the anal verge. Have a colorectal or coloanal reconstruction with or without reservoir/pouch. Subjects who are women of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at Day 0. Have signed an approved informed consent form for the study. Be willing to comply with the protocol. Exclusion Criteria: Undergoing stapled anastomosis with the use of an experimental or non-FDA approved stapler. Undergoing ileoanal reconstruction, total colectomy or proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy). Has received and completed a course of pelvic radiotherapy ≥ 6 months prior to LAR surgery (Day 0). Has previously undergone a left sided colon resection. Has previously undergone a rectal resection. Has recurrent rectal or rectosigmoid cancer. Has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended en bloc operations. Has a diagnosis of Stage IV rectal or rectosigmoid cancer with any multifocal metastases or single site metastasis with tumor size of > 2 cm (Intraoperative incidental finding or preoperative suspicion of Stage IV cancer with isolated (single site) metastasis (≤ 2 cm) or limited metastases (≤3), with largest lesion ≤ 2 cm in size, does not exclude the subject). Has a diagnosis of inflammatory bowel disease (IBD). Subjects with rectal or rectosigmoid cancer neoplasms and IBD are excluded. Has hepatic dysfunction defined as Model for End-Stage Liver Disease (MELD) Score >12. Renal dysfunction defined as creatinine ≥ 2.0 mg/dL. Has known allergy or history of adverse reaction to ICG, iodine or iodine dyes. Has, in the Investigator's opinion, any medical condition that makes the subject a poor candidate for the investigational procedure, or interferes with the interpretation of study results. Is actively participating in another investigational clinical study which, in the Investigator's or Sponsor's opinion, would interfere in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PINPOINT or SPY Elite<br>A low anterior resection will be performed according to the surgeon's standard practice with the addition of intraoperative imaging using PINPOINT near infrared fluorescence imaging or SPY Elite intraoperative imaging to assess colon and rectal tissue perfusion | Device: PINPOINT<br> <br> Device: SPY Elite<br> <br> |
| No Intervention: STANDARD<br>A low anterior resection will be performed according to the surgeon's standard practice | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anastomotic Leak Rate | Anastomotic leak rate in low anterior resection procedures where colon and rectal tissue perfusion is evaluated using PINPOINT Endoscopic Fluorescence imaging or SPY Elite imaging as an adjunct to standard surgical practice compared to surgical procedures performed according to standard surgical practice alone. | Day 0 to Week 8 (+/- 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of SPY Visualization and Tissue Perfusion | The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure | Day 0 (Day of Surgery) | 
| Incidence of Post-Operative Abscess Requiring Surgical Management | Rate of postoperative abscess requiring surgical management. | Day 0 to Week 8 (+/- 2 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal cancer, Rectal neoplasm, Colorectal surgery, Anastomosis