Study Stopped
Slow recruitment
A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
PILLAR III
A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
1 other identifier
interventional
347
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2015
Typical duration for not_applicable
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2014
CompletedFirst Posted
Study publicly available on registry
July 31, 2014
CompletedStudy Start
First participant enrolled
January 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2017
CompletedResults Posted
Study results publicly available
June 24, 2020
CompletedJune 24, 2020
June 1, 2020
2.3 years
July 29, 2014
May 11, 2020
June 22, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Rate of SPY Visualization and Tissue Perfusion
Day 0 (Day of Surgery)
Incidence of Post-Operative Abscess Requiring Surgical Management
Day 0 to Week 8 (+/- 2 weeks)
Study Arms (2)
PINPOINT or SPY Elite
EXPERIMENTALA 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 INTERVENTIONA low anterior resection will be performed according to the surgeon's standard practice
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
John Muir Medical Center, Concord Campus
Concord, California, United States
Kaiser Permanente
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of California, San Francisco
San Francisco, California, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
University of South Florida
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Clinic
New Orleans, Louisiana, 70121, United States
Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Barnes Jewish Medical Center
St Louis, Missouri, United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada, 89109, United States
Mount Sinai Beth Israel
New York, New York, 10003, United States
Mount Sinai Medical Center
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Methodist Hospital
Houston, Texas, United States
Related Publications (1)
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.
PMID: 33872284DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The interpretation of the efficacy results is limited due to the fact that the study was stopped early, which may have adversely affected the statistical power of some tests.
Results Point of Contact
- Title
- Alicia Wilton
- Organization
- Novadaq Technologies
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Stamos, MD
University of California, Irvine
- PRINCIPAL INVESTIGATOR
Steven Wexner, MD
Cleveland Clinic Florida
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2014
First Posted
July 31, 2014
Study Start
January 1, 2015
Primary Completion
May 1, 2017
Study Completion
May 1, 2017
Last Updated
June 24, 2020
Results First Posted
June 24, 2020
Record last verified: 2020-06