Rectal CancerPILLAR IIINCT02205307
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
A study testing PINPOINT and SPY Elite in people with Rectal Cancer and Rectosigmoid Cancer, run by Novadaq Technologies ULC, now a part of Stryker at 24 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Rectosigmoid Cancer
- What is being tested?
- PINPOINT and SPY Elite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 347 participants
- Where
- 24 sitesUnited States
- Study dates
- Jan 2015to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
United States24 sites
Johns Hopkins
Baltimore, Maryland
Massachusetts General Hospital
Boston, Massachusetts
Medical University of South Carolina
Charleston, South Carolina
Rush University Medical Center
Chicago, Illinois
The Christ Hospital
Cincinnati, Ohio
Cleveland Clinic
Cleveland, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio
John Muir Medical Center, Concord Campus
Concord, California
Baylor University Medical Center
Dallas, Texas, 75246
Methodist Hospital
Houston, Texas
Indiana University
Indianapolis, Indiana
Mayo Clinic - Jacksonville
Jacksonville, Florida
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109
Kaiser Permanente
Los Angeles, California
Vanderbilt University Medical Center
Nashville, Tennessee
Ochsner Clinic
New Orleans, Louisiana, 70121
Mount Sinai Beth Israel
New York, New York, 10003
Mount Sinai Medical Center
New York, New York
Weill Cornell Medical College
New York, New York
University of California, Irvine
Orange, California
University of California, San Francisco
San Francisco, California
Barnes Jewish Medical Center
St Louis, Missouri
University of South Florida
Tampa, Florida
Cleveland Clinic Florida
Weston, Florida
About this study
Official title: A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
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.
- Conditions
- Rectal Cancer, Rectosigmoid Cancer
- Being tested
- PINPOINT, SPY Elite
- Keywords
- Rectal cancer, Rectal neoplasm, Colorectal surgery, Anastomosis
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PINPOINTDevice
SPY EliteDevice
| Study group | Role | What they receive |
|---|---|---|
| PINPOINT or SPY Elite | Experimental | 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 Receives: Device: PINPOINT; Device: SPY Elite |
| STANDARD | No intervention | A low anterior resection will be performed according to the surgeon's standard practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0 to Week 8 (+/- 2 weeks)
Secondary outcomes (2)
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
Measured: Day 0 (Day of Surgery)
Incidence of Post-Operative Abscess Requiring Surgical Management
Rate of postoperative abscess requiring surgical management.
Measured: Day 0 to Week 8 (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startJan 2015
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 347 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novadaq Technologies ULC, now a part of Stryker
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael J Stamos, MD, Principal investigator, University of California, IrvineSteven Wexner, MD, Principal investigator, Cleveland Clinic Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205307
- Sponsor's protocol ID
- PP PLR 03
- Acronym
- PILLAR III
- Status last verified
- Jun 2020
- First submitted
- 29 Jul 2014
- Last updated
- 24 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Jafari MD, Pigazzi A, McLemore EC, Mutch MG, Haas E, Rasheid SH, Wait AD, Paquette IM, Bardakcioglu O, Safar B, Landmann RG, Varma MG, Maron DJ, Martz J, Bauer JJ, George VV, Fleshman JW Jr, Steele SR, Stamos MJ. Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection. Dis Colon Rectum. 2021 Aug 1;64(8):995-1002. doi: 10.1097/DCR.0000000000002007.
PubMed 33872284
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
- ClinicalTrials.gov ID
- NCT02205307
- Acronym / sponsor ID
- PILLAR III / PP PLR 03
- Conditions
- Rectal Cancer, Rectosigmoid Cancer
- Keywords
- Rectal cancer, Rectal neoplasm, Colorectal surgery, Anastomosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 347 participants (actual)
- Lead sponsor
- Novadaq Technologies ULC, now a part of StrykerIndustry (pharma, biotech, devices)
- Study start
- Jan 2015
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 31 Jul 2014 (estimated)
- Results
- Posted 24 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PINPOINT or SPY Elite | Experimental | Device: PINPOINT, Device: SPY EliteA 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 |
| STANDARD | No intervention | –A low anterior resection will be performed according to the surgeon's standard practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PINPOINT | Device | PINPOINT or SPY Elite |
| SPY Elite | Device | PINPOINT or SPY Elite |
Primary outcome
Anastomotic Leak Rate
Time frame: 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.
2 secondary outcomes
Rate of SPY Visualization and Tissue Perfusion
Time frame: Day 0 (Day of Surgery)
Incidence of Post-Operative Abscess Requiring Surgical Management
Time frame: Day 0 to Week 8 (+/- 2 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33872284Jafari MD, Pigazzi A, McLemore EC, Mutch MG, Haas E, Rasheid SH, Wait AD, Paquette IM, Bardakcioglu O, Safar B, Landmann RG, Varma MG, Maron DJ, Martz J, Bauer JJ, George VV, Fleshman JW Jr, Steele SR, Stamos MJ. Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection. Dis Colon Rectum. 2021 Aug 1;64(8):995-1002. doi: 10.1097/DCR.0000000000002007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Stamos, MD principal investigator
University of California, Irvine
Steven Wexner, MD principal investigator
Cleveland Clinic Florida
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PINPOINT and SPY Elite in people with Rectal Cancer and Rectosigmoid Cancer, run by Novadaq Technologies ULC, now a part of Stryker at 24 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anastomotic Leak Rate (time frame: Day 0 to Week 8 (+/- 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02205307, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.