A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection

Overview

  • Study type

    Interventional
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Jacksonville, Florida: 14-009570
    NCT ID: NCT02205307
    Sponsor Protocol Number: PP PLR 03

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 18 years of age and older
  • Undergoing an LAR for the treatment of rectal neoplasms
  • Subjects with rectal neoplasm(s) may be treated with or without neoadjuvant therapy. Neoadjuvant therapy must have been completed ≥6 weeks prior to surgery
  • Have a planned low circular stapled or transanally hand sewn anastomosis ≤10 cm from the anal verge, with or without reservoir/pouch

Exclusion Criteria:

  • Undergoing a robotic or robotic assisted (da Vinci® Surgical System) LAR
  • Undergoing ileoanal reconstruction, proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy)
  • Diagnosis of Stage IV rectal cancer or locally advanced rectal cancer undergoing extended en bloc operations
  • Intra-operative incidental finding of Stage IV cancer with isolated metastasis of a cumulative size of ≤ 2 cm does not exclude the subject
  • Diagnosis of inflammatory bowel disease
  • Hepatic dysfunction defined as MELD Score >10
  • Renal dysfunction with creatinine >2.0
  • Known allergy or history of adverse reaction to ICG, iodine or iodine dyes
  • Pregnant or lactating female

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Ron Landmann, M.D.

Closed for enrollment

Contact information:

Mauricia Buchanan R.N., C.C.R.C.

(904)953-9455

Buchanan.Mauricia@mayo.edu

.
CLS-20146808

Mayo Clinic Footer