Clinical trial · Interventional
Examination of Rectal Blood Supply During Rectal Cancer Surgery Using Laser Speckle Contrast Imaging
Laser Speckle Contrast Imaging for Rectal Anastomotic Evaluation (LIRA): A Feasibility Study.
NCT07799740CI-TRIAL-00125208LIRAnot yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 12, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260912-000001
Summary
Brief summary (as posted)
This multicentre feasibility study evaluates the feasibility of performing laparoscopic Laser Speckle Contrast Imaging (LSCI) measurements of rectal perfusion during rectal cancer surgery. To our knowledge, LSCI has not previously been applied laparoscopically for intraoperative assessment of rectal perfusion in this setting. Laparoscopic LSCI measurements will be compared with indocyanine green fluorescence imaging, and associations between quantitative measures of colorectal perfusion and postoperative outcomes, including anastomotic leakage, will be explored.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indocyanine Green (ICG) | — | UNRESOLVED | — |
| Laser Speckle Contrast Imaging | — | UNRESOLVED | — |
| Optical Imaging | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Total Mesorectal Excision | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laser speckle contrast imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative aided assessment of intestinal microcirculation
- description
- Participants undergoing total mesorectal excision (TME) for rectal cancer will undergo intraoperative assessment of rectal perfusion using laser speckle contrast imaging (LSCI) and indocyanine green fluorescence imaging (ICG-FI). Four to six days after TME, all participants will undergo computed tomography (CT) with intravenous contrast and a rectal contrast enema to assess for anastomotic leakage. Participants must be older than 18 years of age and provide informed consent prior to inclusion.
- interventionNames
- Device: Laser speckle contrast imaging
Primary outcomes (3)
- measure
- Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging
- timeFrame
- Intraoperatively
- description
- Feasibility is considered demonstrated if time spent on PerfusiX-Imaging measurements is ≤ 5% of total operating time and no more than two measurements are required to obtain a sufficient assessment of intestinal microcirculation. Unit: Percentage of participants with succesful assessment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Rectal cancer * Surgical strategy either partial or total mesorectal excision * Able to provide informed consent Exclusion Criteria: \- Allergy to iodine
References
Publications (17)
- RESULTDanish Colorectal Cancer Group, DCCG Årsrapport 1. januar 2023 - 31. december 2023.
- RESULTPower SP, Moloney F, Twomey M, James K, O'Connor OJ, Maher MM. Computed tomography and patient risk: Facts, perceptions and uncertainties. World J Radiol. 2016 Dec 28;8(12):902-915. doi: 10.4329/wjr.v8.i12.902. PMID 28070242
- RESULTAxt S, Haller K, Wilhelm P, Falch C, Martus P, Johannink J, Rolinger J, Beltzer C, Axt L, Konigsrainer A, Kirschniak A. Early postoperative endoscopic evaluation of rectal anastomoses: a prospective cross-sectional study. Surg Endosc. 2022 Dec;36(12):8881-8892. doi: 10.1007/s00464-022-09323-6. Epub 2022 May 23. PMID 35606545
- RESULTValentin J; International Commission on Radiation Protection. Managing patient dose in multi-detector computed tomography(MDCT). ICRP Publication 102. Ann ICRP. 2007;37(1):1-79, iii. doi: 10.1016/j.icrp.2007.09.001. PMID 18069128
- RESULTBowen DJ, Kreuter M, Spring B, Cofta-Woerpel L, Linnan L, Weiner D, Bakken S, Kaplan CP, Squiers L, Fabrizio C, Fernandez M. How we design feasibility studies. Am J Prev Med. 2009 May;36(5):452-7. doi: 10.1016/j.amepre.2009.02.002. PMID 19362699
- RESULTHeuvelings DJI, Al-Taher M, Calon J, Chand M, Stassen LPS, Lubbers T, Wevers KP, Boni L, Bouvy ND, Heeman W. Real-time intestinal perfusion assessment for anastomotic site selection using laser speckle contrast imaging: Verification in a porcine model. Surg Open Sci. 2025 Apr 18;26:12-17. doi: 10.1016/j.sopen.2025.04.007. eCollection 2025 Jun. PMID 40933467
- RESULTHirst A, Philippou Y, Blazeby J, Campbell B, Campbell M, Feinberg J, Rovers M, Blencowe N, Pennell C, Quinn T, Rogers W, Cook J, Kolias AG, Agha R, Dahm P, Sedrakyan A, McCulloch P. No Surgical Innovation Without Evaluation: Evolution and Further Development of the IDEAL Framework and Recommendations. Ann Surg. 2019 Feb;269(2):211-220. doi: 10.1097/SLA.0000000000002794.