Clinical trial NCT02205307: A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Official title: A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectal Cancer
Rectosigmoid Cancer
Keywords: Rectal cancer
Rectal neoplasm
Colorectal surgery
Anastomosis
Lead sponsor: Novadaq Technologies ULC, now a part of Stryker
Sponsor class: INDUSTRY
First posted: 2014-07-31
Enrollment: 347
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anastomotic Leak Rate
timeFrame: Day 0 to Week 8 (+/- 2 weeks)
Secondary outcomes:
measure: Rate of SPY Visualization and Tissue Perfusion
timeFrame: Day 0 (Day of Surgery)
measure: Incidence of Post-Operative Abscess Requiring Surgical Management
timeFrame: Day 0 to Week 8 (+/- 2 weeks)
Other outcomes:
Locations:
city: Concord
country: United States
facility: John Muir Medical Center, Concord Campus
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Orange
country: United States
facility: University of California, Irvine
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Ochsner Clinic
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Barnes Jewish Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Sunrise Hospital and Medical Center
state: Nevada
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Houston
country: United States
facility: Methodist Hospital
state: Texas
Study officials:
affiliation: University of California, Irvine
name: Michael J Stamos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland Clinic Florida
name: Steven Wexner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.