Examination of Rectal Blood Supply During Rectal Cancer Surgery Using Laser Speckle Contrast Imaging

NCT07799740 | Not Yet Recruiting DMC

• 1 other identifier: 1068706
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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

Rectal Cancer; Total Mesorectal Excision; Laser Speckle Contrast Imaging; Indocyanine Green (ICG); Optical Imaging

Keywords

Laser speckle contrast imaging; Rectal cancer; Total Mesorectal Excision; Indocyanine Green Fluorescent Imaging

Outcome Measures

Primary Outcomes (3)

• Technical feasibility of intraoperative microcirculation assessment using PerfusiX-Imaging

  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

  Intraoperatively

• Surgeon-reported acceptability of PerfusiX-Imaging

  Surgeons will assess the acceptability and performance of PerfusiX-Imaging using a predefined Likert-scale questionnaire. Feasibility will be considered demonstrated if \>80% of surgeons report a positive evaluation of PerfusiX-Imaging. A positive evaluation is defined as a Likert score of ≥ 4 on at least three of the four predefined evaluation questions. Unit: Percentage of surgeons with a positive evaluation

  intraoperatively

• Potential impact of PerfusiX-Imaging on surgical decision making

  The distance between the marked oral transection line with and without the use of PerfusiX-Imaging given by the surgeon and an independent expert. Feasibility will be considered demonstrated if the transection line differs by ≥ 10 mm. Unit: milimetres (mm)

  Intraoperatively

Secondary Outcomes (8)

• Comparison of surgeon-reported acceptability between PerfusiX-Imaging and ICG-FI

  Immediately after surgery

• Absolute intestinal microcirculation

  Intraoperatively

• Relative intestinal microcirculation

  Intraoperatively

• Length of initial hospital stay after surgery

  From the end of surgery until initial hospital discharge, up to 30 days after surgery

• Severity of postoperative complications according to the Clavien-Dindo classification

  30 days after surgery

Study Arms (1)

Intraoperative aided assessment of intestinal microcirculation

EXPERIMENTAL

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.

Device: Laser speckle contrast imaging

Interventions

Laser speckle contrast imaging DEVICE

Investigated device: PerfusiX-Imaging, LIMIS Development B.V., The Netherlands ICG-FI: Verdye, 0.2 mg/kg, Firefly® fluorescence imaging PerfusiX-Imaging is used Intracorporally prior to anal specimen transection, extracoporally prior to oral speciamen transection, intracorporally assessing the free bowel ends prior to anastomotic formation. ICG-FI is applied intracorporally assessing the free bowel ends prior to anastomotic formation. Diagnostic imaging: All participants undergo computed tomography with intravenous contrast and a rectal contrast enema.

Intraoperative aided assessment of intestinal microcirculation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Rectal cancer
• Surgical strategy either partial or total mesorectal excision
• Able to provide informed consent

You may not qualify if:

• \- Allergy to iodine

Sponsors & Collaborators

• University of Aarhus: lead
• Gødstrup Hospital: collaborator
• Vejle Hospital: collaborator

Study Sites (2)

Regional Hospital Gødstrup

Herning, Denmark

Location

Sygehus Lillebælt, Vejle Hospital

Vejle, Denmark

Location

Related Publications (17)

• Danish Colorectal Cancer Group, DCCG Årsrapport 1. januar 2023 - 31. december 2023.

  RESULT

• Power 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 RESULT

• Axt 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 RESULT

• Valentin 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 RESULT

• Bowen 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 RESULT

• Heuvelings 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 RESULT

• Hirst 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.

  PMID: 29697448 RESULT

• Heeman W, Steenbergen W, van Dam G, Boerma EC. Clinical applications of laser speckle contrast imaging: a review. J Biomed Opt. 2019 Aug;24(8):1-11. doi: 10.1117/1.JBO.24.8.080901.

  PMID: 31385481 RESULT

• Coraci MM, Schouw HM, Kruijff S, Mao Y, Noltes ME, Heeman W. Comparison of quantitative laser speckle contrast and indocyanine green imaging for intestinal perfusion measurements in robot assisted surgery. Sci Rep. 2025 Jul 1;15(1):21664. doi: 10.1038/s41598-025-05496-x.

  PMID: 40596151 RESULT

• Heeman W, Calon J, van der Bilt A, Pierie JEN, Pereboom I, van Dam GM, Boerma EC. Dye-free visualisation of intestinal perfusion using laser speckle contrast imaging in laparoscopic surgery: a prospective, observational multi-centre study. Surg Endosc. 2023 Dec;37(12):9139-9146. doi: 10.1007/s00464-023-10493-0. Epub 2023 Oct 9.

  PMID: 37814165 RESULT

• Paramasivam R, Jaensch C, Madsen AH, Orntoft MW. Intraoperative assessment of anastomotic microcirculation during right hemicolectomy with real-time laser speckle contrast imaging is safe and feasible. Colorectal Dis. 2025 Jul;27(7):e70162. doi: 10.1111/codi.70162.

  PMID: 40671310 RESULT

• Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.

  PMID: 39151436 RESULT

• Mc Entee PD, Singaravelu A, Boland PA, Moynihan A, Creavin B, Cahill RA. Impact of indocyanine green fluorescence angiography on surgeon action and anastomotic leak in colorectal resections. A systematic review and meta-analysis. Surg Endosc. 2025 Mar;39(3):1473-1489. doi: 10.1007/s00464-025-11582-y. Epub 2025 Feb 3.

  PMID: 39900861 RESULT

• Fang C, Nie P, Jing P, Zhang Y, Yang L, Yu Y, Wang C, Zhou Z. Effects of Adjuvant Therapy Compliance and Anastomotic Leakage on the Oncologic Outcomes of Patients With Rectal Cancer After Curative Resection. Dis Colon Rectum. 2021 Jun 1;64(6):689-696. doi: 10.1097/DCR.0000000000001824.

  PMID: 33394777 RESULT

• Gielen AHC, Heuvelings DJI, Sylla P, van Loon YT, Melenhorst J, Bouvy ND, Kimman ML, Breukink SO; CoReAL Collaborative. Impact of Anastomotic Leakage After Colorectal Cancer Surgery on Quality of Life: A Systematic Review. Dis Colon Rectum. 2025 Feb 1;68(2):154-170. doi: 10.1097/DCR.0000000000003478. Epub 2024 Oct 23.

  PMID: 39440840 RESULT

• Wang S, Liu J, Wang S, Zhao H, Ge S, Wang W. Adverse Effects of Anastomotic Leakage on Local Recurrence and Survival After Curative Anterior Resection for Rectal Cancer: A Systematic Review and Meta-analysis. World J Surg. 2017 Jan;41(1):277-284. doi: 10.1007/s00268-016-3761-1.

  PMID: 27743072 RESULT

• Hernandez PT, Paspulati RM, Shanmugan S. Diagnosis of Anastomotic Leak. Clin Colon Rectal Surg. 2021 Nov 23;34(6):391-399. doi: 10.1055/s-0041-1735270. eCollection 2021 Nov.

  PMID: 34853560 RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Laser Speckle Contrast Imaging

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Central Study Contacts

Mai-Britt W. Ørntoft, MD, Ph.D, Ass. Professor

CONTACT

+45 61670561; mwo@clin.au.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label trial. Participants, surgeons, and other study personnel are aware of the study procedures. However, the LSCI measurements are not available to the surgeons during the surgical procedure and are only revealed after completion of the surgery. Therefore, the LSCI measurements cannot influence the surgeons' intraoperative decision-making regarding creation of the rectal anastomosis.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The primary objective of this clinical investigation is to assess the feasibility of performing laparoscopic laser speckle contrast imaging (LSCI) measurements of intestinal perfusion during rectal cancer surgery. Feasibility will be evaluated in terms of technical feasibility, usability and acceptability among surgeons, and potential influence on surgical decision-making. Secondary objectives include comparison of LSCI with indocyanine green fluorescence imaging, assessment of quantitative perfusion measurements, and exploration of associations between perfusion measurements and postoperative outcomes.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)