A Study Assessing Perfusion Outcomes With PINPOINT® Near Infrared Fluorescence Imaging in Low Anterior Resection
Overview
Tab Title Description
Study type
InterventionalDescribes 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.
Study IDs
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Ron Landmann, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available