Colon Cancer, Crohn's Disease, Diverticulitis, Polyp, Procidentia, Rectal Cancer
Conditions
Keywords
Laparoscopic low anterior colon resection, Laparoscopic left colectomy, Colectomy, Rectal cancer, Colon cancer, Crohn's Disease, Polyp, Procidentia, Diverticulitis
Brief summary
The purpose of this study is to demonstrate that NIR fluorescence angiography using the PINPOINT Endoscopic Fluorescence Imaging System (PINPOINT System or PINPOINT) can assess viability of colon tissue during laparoscopic left colectomy. This information will provide the surgeon with clinically relevant information in assessing whether or not the tissue has adequate blood supply in the lower section of the colon prior to a colectomy.
Detailed description
Colectomy is a surgical procedure in which a part or all of the colon is removed. It is used to treat a variety of diseases including colon cancer, diverticulitis, inflammatory bowel disease (including ulcerative colitis or Crohn's disease) and infarcted bowel. This study is the second phase of a three phase process to demonstrate the clinical utility of perfusion assessment by NIR fluorescence angiography in colectomy. The initial phase (Phase I) consisted of a number of small investigative studies that have now been completed. Upon successful completion of this study, it is anticipated that a prospective, multi center, randomized trial will be conducted (Phase III). Information learned from this present study will help guide the design of the randomized trial e.g. specific patient populations that may best benefit from this imaging modality and how randomization should be conducted (e.g. imaged cohort vs. non imaged, or all subjects imaged but then randomized to no image assessment in one arm of the study).
Interventions
The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
Sponsors
Novadaq Technologies ULC, now a part of Stryker
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is scheduled for laparoscopic left colectomy in the lower region (planned anastomosis located 5 - 15 cm from anal verge) * A negative pregnancy test for women of childbearing potential prior to surgery
Exclusion criteria
* Subject has a previous history of adverse reaction or known allergy to ICG, iodine or iodine dyes * Subject has any medical condition, which in the judgment of the Investigator and/or designee makes the subject a poor candidate for the investigational procedure * Subject is a pregnant or lactating female
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PINPOINT System Utility in Left Colectomy Surgery | Day of Operation - Day 1 | To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the PINPOINT System | Through hospital discharge or at 30 days post procedure, whichever is later | To assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance. |
Countries
United States
Participant flow
Recruitment details
A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Patients were enrolled at 11 centers in the United States.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Imaged With PINPOINT Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract.
PINPOINT Endoscopic Fluorescence Imaging System: The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery | 139 |
| Total | 139 |
Baseline characteristics
| Characteristic | Subjects Imaged With PINPOINT |
|---|---|
| Age, Continuous | 58 years |
| ASA Classification (American Society of Anesthesiologists) III (patient with severe systemic disease) | 46 Participants |
| ASA Classification (American Society of Anesthesiologists) II (patient with mild systemic disease) | 73 Participants |
| ASA Classification (American Society of Anesthesiologists) I (normal healthy patient) | 17 Participants |
| ASA Classification (American Society of Anesthesiologists) IV (severe life threating systemic disease) | 3 Participants |
| BMI BMI < 30 kg/m^2 | 97 Participants |
| BMI BMI > 30 kg/m^2 | 42 Participants |
| Diagnosis Colon cancer | 29 Participants |
| Diagnosis Colovesical fistula | 1 Participants |
| Diagnosis Crohn's disease | 1 Participants |
| Diagnosis Diverticulitis | 61 Participants |
| Diagnosis Polyp | 6 Participants |
| Diagnosis Procidentia | 4 Participants |
| Diagnosis Radiation stricture | 1 Participants |
| Diagnosis Rectal cancer | 35 Participants |
| Diagnosis Sigmoid volvulus | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 129 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Preoperative chemotherapy No | 126 Participants |
| Preoperative chemotherapy Yes | 13 Participants |
| Preoperative radiation therapy No | 124 Participants |
| Preoperative radiation therapy Yes | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants |
| Race (NIH/OMB) White | 106 Participants |
| Region of Enrollment United States | 139 participants |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 74 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 139 |
| serious Total, serious adverse events | 23 / 139 |
Outcome results
Primary
PINPOINT System Utility in Left Colectomy Surgery
To demonstrate the utility of intra-operative assessment of colon perfusion, using the PINPOINT System to optimize the location at which to transect the colon in laparoscopic left colectomies and to assess mucosal perfusion of the completed anastomosis following proximal anastomosis in laparoscopic left colectomy.
Time frame: Day of Operation - Day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Imaged With PINPOINT | PINPOINT System Utility in Left Colectomy Surgery | Change to surgical plan due to Fluorescence | 11 Participants |
| Subjects Imaged With PINPOINT | PINPOINT System Utility in Left Colectomy Surgery | No change to surgical plan due to Fluorescence | 128 Participants |
Secondary
Safety of the PINPOINT System
To assess safety related outcomes of the laparoscopic left colectomies with intra-operative assessment of perfusion using the PINPOINT Endoscopic Fluorescence Imaging System for guidance.
Time frame: Through hospital discharge or at 30 days post procedure, whichever is later
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjects Imaged With PINPOINT | Safety of the PINPOINT System | No major post-operative clinical complication | 125 Participants |
| Subjects Imaged With PINPOINT | Safety of the PINPOINT System | Clinical anastomotic leak & confirmed by radiology | 2 Participants |
| Subjects Imaged With PINPOINT | Safety of the PINPOINT System | Post-operative fever | 7 Participants |
| Subjects Imaged With PINPOINT | Safety of the PINPOINT System | Delay in return of bowel function | 5 Participants |