PILLAR II: Perfusion Assessment in Laparoscopic Left Anterior Resection
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Subjects Imaged with PINPOINT Colonic tissue perfusion assessed with PINPOINT for laparoscopic left colectomy in the lower tract. |
Device: 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
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90089 |
| 2 | University of California, Irvine | Orange | California | United States | 92868 |
| 3 | University of California San Diego | San Diego | California | United States | 92093 |
| 4 | University of California San Francisco | San Francisco | California | United States | 94115 |
| 5 | Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
| 6 | Ochsner Medical Center | New Orleans | Louisiana | United States | 70121 |
| 7 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 8 | Maimonides Medical Center | Brooklyn | New York | United States | 11219 |
| 9 | Beth Israel Medical Center | New York | New York | United States | 10003 |
| 10 | Weill Cornell Medical College | New York | New York | United States | 10021 |
| 11 | University Hospital Case Medical Center | Cleveland | Ohio | United States | 44106 |
Sponsors and Collaborators
- Novadaq Technologies ULC, now a part of Stryker
Investigators
- Principal Investigator: Michael J Stamos, MD, University of California, Irvine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Version 1
Study Results
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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Subjects Imaged With PINPOINT |
|---|---|
| Arm/Group Description | 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 |
| Period Title: Overall Study | |
| STARTED | 147 |
| Eligible for Analysis | 139 |
| COMPLETED | 147 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Subjects Imaged With PINPOINT |
|---|---|
| Arm/Group Description | 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 |
| Overall Participants | 139 |
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
58
|
| Sex: Female, Male (Count of Participants) | |
| Female |
65
46.8%
|
| Male |
74
53.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
10
7.2%
|
| Not Hispanic or Latino |
129
92.8%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
14
10.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
7
5%
|
| White |
106
76.3%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
12
8.6%
|
| Region of Enrollment (participants) [Number] | |
| United States |
139
100%
|
| ASA Classification (American Society of Anesthesiologists) (Count of Participants) | |
| I (normal healthy patient) |
17
12.2%
|
| II (patient with mild systemic disease) |
73
52.5%
|
| III (patient with severe systemic disease) |
46
33.1%
|
| IV (severe life threating systemic disease) |
3
2.2%
|
| BMI (Count of Participants) | |
| BMI > 30 kg/m^2 |
42
30.2%
|
| BMI < 30 kg/m^2 |
97
69.8%
|
| Preoperative chemotherapy (Count of Participants) | |
| Yes |
13
9.4%
|
| No |
126
90.6%
|
| Preoperative radiation therapy (Count of Participants) | |
| Yes |
15
10.8%
|
| No |
124
89.2%
|
| Diagnosis (Count of Participants) | |
| Diverticulitis |
61
43.9%
|
| Rectal cancer |
35
25.2%
|
| Colon cancer |
29
20.9%
|
| Polyp |
6
4.3%
|
| Procidentia |
4
2.9%
|
| Crohn's disease |
1
0.7%
|
| Colovesical fistula |
1
0.7%
|
| Radiation stricture |
1
0.7%
|
| Sigmoid volvulus |
1
0.7%
|
Outcome Measures
| Title | PINPOINT System Utility in Left Colectomy Surgery |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Subjects Imaged With PINPOINT |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 139 |
| Change to surgical plan due to Fluorescence |
11
7.9%
|
| No change to surgical plan due to Fluorescence |
128
92.1%
|
| Title | Safety of the PINPOINT System |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Subjects Imaged With PINPOINT |
|---|---|
| Arm/Group Description | 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 |
| Measure Participants | 139 |
| Clinical anastomotic leak & confirmed by radiology |
2
1.4%
|
| Post-operative fever |
7
5%
|
| Delay in return of bowel function |
5
3.6%
|
| No major post-operative clinical complication |
125
89.9%
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Subjects Imaged With PINPOINT | |
| Arm/Group Description | 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 | |
All Cause Mortality |
||
| Subjects Imaged With PINPOINT | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Subjects Imaged With PINPOINT | ||
| Affected / at Risk (%) | # Events | |
| Total | 23/139 (16.5%) | |
| Blood and lymphatic system disorders | ||
| Blood transfusion | 1/139 (0.7%) | |
| Cardiac disorders | ||
| Hypertension | 1/139 (0.7%) | |
| Gastrointestinal disorders | ||
| Ileus | 1/139 (0.7%) | |
| Ileus requiring nasogastric tube | 1/139 (0.7%) | |
| Small bowel obstruction | 1/139 (0.7%) | |
| Incisional hernia | 1/139 (0.7%) | |
| Vomiting | 2/139 (1.4%) | |
| Constipation | 1/139 (0.7%) | |
| General disorders | ||
| Fever | 1/139 (0.7%) | |
| Hepatobiliary disorders | ||
| Hypokalemia | 1/139 (0.7%) | |
| Infections and infestations | ||
| Pelvic abscess | 2/139 (1.4%) | |
| Abdominal wall infection | 1/139 (0.7%) | |
| C. difficile colitis | 2/139 (1.4%) | |
| Wound infection | 1/139 (0.7%) | |
| Renal and urinary disorders | ||
| Acute renal failure | 1/139 (0.7%) | |
| Urinary retention | 1/139 (0.7%) | |
| Urinary tract infection | 1/139 (0.7%) | |
| Surgical and medical procedures | ||
| Anastomotic leak | 2/139 (1.4%) | |
| Vascular disorders | ||
| Thrombosed left renal artery | 1/139 (0.7%) | |
Other (Not Including Serious) Adverse Events |
||
| Subjects Imaged With PINPOINT | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/139 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Alicia Wilton |
|---|---|
| Organization | Novadaq Technologies, Inc. |
| Phone | 1.905.629.3822 ext 209 |
| awilton@novadaq.com |
- Version 1