Rectal Cancer, Rectosigmoid Cancer
Conditions
Keywords
Rectal cancer, Rectal neoplasm, Colorectal surgery, Anastomosis
Brief summary
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.
Interventions
DEVICEPINPOINT
DEVICESPY Elite
Sponsors
Novadaq Technologies ULC, now a part of Stryker
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anastomotic Leak Rate | Day 0 to Week 8 (+/- 2 weeks) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of SPY Visualization and Tissue Perfusion | Day 0 (Day of Surgery) | The ability of PINPOINT or SPY Elite to provide sufficient visualization for assessment of blood flow and related tissue perfusion during the procedure |
| Incidence of Post-Operative Abscess Requiring Surgical Management | Day 0 to Week 8 (+/- 2 weeks) | Rate of postoperative abscess requiring surgical management. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PINPOINT or SPY Elite 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 | 178 |
| STANDARD A low anterior resection will be performed according to the surgeon's standard practice | 169 |
| Total | 347 |
Baseline characteristics
| Characteristic | PINPOINT or SPY Elite | STANDARD | Total |
|---|---|---|---|
| Age, Customized Mean | 57.2 years STANDARD_DEVIATION 11.14 | 56.5 years STANDARD_DEVIATION 11.59 | 56.9 years STANDARD_DEVIATION 11.36 |
| Alcohol Consumption No | 97 Participants | 89 Participants | 186 Participants |
| Alcohol Consumption Yes | 81 Participants | 80 Participants | 161 Participants |
| Height | 171.89 cm STANDARD_DEVIATION 9.814 | 171.32 cm STANDARD_DEVIATION 9.79 | 171.61 cm STANDARD_DEVIATION 9.792 |
| Long-Course Neoadjuvant Therapy No | 65 Participants | 58 Participants | 123 Participants |
| Long-Course Neoadjuvant Therapy Yes | 113 Participants | 111 Participants | 224 Participants |
| MELD Score (Model for End-Stage Liver Disease) | 6.8 units on a scale (6-40) STANDARD_DEVIATION 1.06 | 6.7 units on a scale (6-40) STANDARD_DEVIATION 1.36 | 6.8 units on a scale (6-40) STANDARD_DEVIATION 1.22 |
| Pre-Operative Diagnosis Other | 4 Participants | 1 Participants | 5 Participants |
| Pre-Operative Diagnosis Polyp | 3 Participants | 1 Participants | 4 Participants |
| Pre-Operative Diagnosis Rectal Cancer | 144 Participants | 143 Participants | 287 Participants |
| Pre-Operative Diagnosis Rectosigmoid Cancer | 27 Participants | 24 Participants | 51 Participants |
| Race/Ethnicity, Customized Race/Ethnicity African American | 23 Participants | 14 Participants | 37 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 7 Participants | 14 Participants | 21 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 23 Participants | 14 Participants | 37 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 2 Participants | 5 Participants | 7 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 123 Participants | 122 Participants | 245 Participants |
| Sex: Female, Male Female | 69 Participants | 70 Participants | 139 Participants |
| Sex: Female, Male Male | 109 Participants | 99 Participants | 208 Participants |
| Smoking Status No | 126 Participants | 138 Participants | 264 Participants |
| Smoking Status Yes | 52 Participants | 31 Participants | 83 Participants |
| Weight | 82.49 kg STANDARD_DEVIATION 19.743 | 83.11 kg STANDARD_DEVIATION 19.815 | 82.79 kg STANDARD_DEVIATION 19.752 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 3 / 171 | 1 / 168 | 0 / 8 |
| other Total, other adverse events | 155 / 171 | 146 / 168 | 2 / 8 |
| serious Total, serious adverse events | 44 / 171 | 52 / 168 | 0 / 8 |
Outcome results
Primary
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.
Time frame: Day 0 to Week 8 (+/- 2 weeks)
Population: Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PINPOINT or SPY Elite | Anastomotic Leak Rate | Subjects with Post-Operative Anastomotic Leak | 14 Participants |
| PINPOINT or SPY Elite | Anastomotic Leak Rate | Subjects Known to be Anastomotic Leak Free | 148 Participants |
| PINPOINT or SPY Elite | Anastomotic Leak Rate | Unknown/Lost to Follow Up | 13 Participants |
| STANDARD | Anastomotic Leak Rate | Subjects with Post-Operative Anastomotic Leak | 16 Participants |
| STANDARD | Anastomotic Leak Rate | Subjects Known to be Anastomotic Leak Free | 148 Participants |
| STANDARD | Anastomotic Leak Rate | Unknown/Lost to Follow Up | 4 Participants |
Secondary
Incidence of Post-Operative Abscess Requiring Surgical Management
Rate of postoperative abscess requiring surgical management.
Time frame: Day 0 to Week 8 (+/- 2 weeks)
Population: Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PINPOINT or SPY Elite | Incidence of Post-Operative Abscess Requiring Surgical Management | Yes | 10 Participants |
| PINPOINT or SPY Elite | Incidence of Post-Operative Abscess Requiring Surgical Management | No | 165 Participants |
| STANDARD | Incidence of Post-Operative Abscess Requiring Surgical Management | Yes | 7 Participants |
| STANDARD | Incidence of Post-Operative Abscess Requiring Surgical Management | No | 161 Participants |
Secondary
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
Time frame: Day 0 (Day of Surgery)
Population: Modified Intent-to-Treat (mITT): the mITT analysis population includes all randomized subjects in whom a low anterior resection surgical procedure is initiated or at least one injection with ICG was performed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PINPOINT or SPY Elite | Rate of SPY Visualization and Tissue Perfusion | 167 Participants |