Laser Speckle Contrast Imaging, Surgical Eye & ICG Fluorescence Imaging for Perfusion Assessment of the Gastric Conduit

NCT05685862 | Unknown

• 1 other identifier: NL81217.099.22
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale Globally, esophageal cancer is the seventh most common cancer type, with over half a million cases reported in 2020. The survival of gastroesophageal cancer is poor and the prognosis is primarily determined by the possibilities for curative treatment. After resection of part of the esophagus and cardia, the reconstruction of the esophagus is performed with a gastric conduit where an anastomosis is made with the proximal esophageal stump. Globally, a Minimally invasive Esophagectomy (MIE) has a high morbidity rate and a mortality rate ranging up to 5% as a result of the procedure. One of the most feared complications is an anastomotic leakage (AL) with a rate of around 12.5% and a mortality rate of around 15%. AL is associated with prolonged hospital stay and increased re-operation rates. It is generally accepted that impaired blood flow of the gastric conduit is the most important cause of AL. The surgical procedure of an esophagectomy and reconstruction inherently compromises the blood supply of the gastric conduit. However other than the surgical eye, there is no gold standard in assessing this. Surgeons generally look for traditional indicators of tissue viability such as pulsating vessels, bleeding of the resected edges, tissue color and intestinal motility. However, an objective indication of the tissue perfusion is still lacking, implying the clinical need for one. Objectives In this trial the investigators will study the utility of PerfusiX-Imaging for perfusion assessment of the gastric conduit in comparison with the standard of care. Study design The current study is a prospective, observational single-center study in the Medical Center Leeuwarden. Study population A total of 30 patients undergoing an esophageal resection will be included. Patient related study procedures All patients will undergo the standard-of-care program which includes perfusion assessment by the surgical eye and ICG-fluorescence imaging. In addition to this standard-of-care, 2D-perfusion maps will be generated from images taken with PerfusiX-Imaging (LIMIS Development BV, Leeuwarden, The Netherlands) in combination with a standard surgical laparoscope. Not related to the patient, the PerfusiX-Imaging images will be shown to the surgeon postoperatively and peroperative questionnaires will be filled regarding the standard-of-care perfusion assessment. Study parameters/endpoints Due to the explorative character of this study, there is no formal hierarchy in the respective endpoints of this study. In this, all endpoints will add to the overall assessment of the feasibility of the PerfusiX-imaging derived visual feedback. The investigators will look at the percentage of operating surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. The percentage of the non-involved surgeons that indicated no change in location of the anastomosis or operating plan based on the additional PerfusiX-Imaging. And the homogeneity of the change in location between non-involved surgeons for individual patients will be analyzed in order to get a sense for the subjectivity of the interpretation of the images. The investigators will also compare the additional PerfusiX-Imaging derived visual feedback to the standard of care by looking at the homogeneity in location of the watershed area between PerfusiX-Imaging, ICG-fluorescence and based on visual assessment by the surgical eye. The difference in the location of watershed area between PerfusiX-Imaging and ICG-fluorescence or based on visual assessment. In order to get a sense of the scale of the indicated change in location of the anastomosis the investigators will look at the estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by the operating surgeon. The estimated change in location of the anastomosis of the gastric conduit/ the esophageal stump in centimeters by non-involved surgeons. Lastly, the investigators will compare the change in the location of the anastomosis by non-involved surgeons in comparison to the operating surgeon; Burden, risk and benefit to participation Burden Not applicable. Risks Not applicable. Benefit Not applicable.

Conditions

Oesophageal Cancer

Keywords

Laser Speckle Contrast Imaging; LSCI; gastric conduit; oesophageal cancer; ICG; fluorescence

Outcome Measures

Primary Outcomes (12)

• Indication of change in location or operating plan of anastomosis by operating surgeon based on PerfusiX-Imaging in comparison to standard-of-care

  \- Number of operating surgeons to indicate a change in location of anastomosis (Yes/no, %, with 95% confidence interval)

  1 day

• Indication of change in location or operating plan of anastomosis non-involved surgeon based on PerfusiX-Imaging in comparison to standard-of-care

  \- Number of non-involved surgeons to indicate a change in location of anastomosis (Yes/no, %, with 95% confidence interval)

  1 day

• Difference in location of watershed area

  \- Difference in location of watershed area in centimeters between PerfusiX, ICG-fluorescence and surgical eye (Means with standard deviation, median with range)

  1 day

• Estimated direction of change in location by operating surgeon in comparison to standard-of-care

  \- Proximal or medial direction of change (Yes/no, %, with 95% confidence interval)

  1 day

• Estimated distance of change in location by operating surgeon in comparison to standard-of-care

  \- Change in location of anastomosis in centimeters (Means with standard deviation, median with range)

  1 day

• Estimated direction of change in location by non-involved surgeon in comparison to standard-of-care

  \- Proximal or medial direction of change (Yes/no, %)

  1 week

• Estimated distance of change in location by non-involved surgeon in comparison to standard-of-care

  \- Change in location of anastomosis in centimeters (Means with standard deviation, median with range)

  1 week

• Indication of change in direction of anastomosis non-involved surgeon based on PerfusiX-Imaging in comparison to standard-of-care

  \- Proximal or medial direction of change (Yes/no, %, with 95% confidence interval)

  1 week

• Indication of change in centimeters of anastomosis non-involved surgeon based on PerfusiX-Imaging in comparison to standard-of-care

  \- Change in location of anastomosis in centimeters (Means with standard deviation, median with range)

  1 week

• Development of anastomotic leakage

  \- Number of patients developing AL (Percentage, %, with 95% confidence interval)

  3 months from the moment of surgery

• Characteristics of anastomotic leakage if present

  \- AL characteristics (localization, tumor type, type of hemicolectomy, diagnosed with, treatment)

  3 months from the moment of surgery

• Extra time taken for imaging

  \- Extra time taken for imaging protocol in seconds (Means with standard deviation, median with range)

  1 day, during surgery.

Study Arms (1)

Group 1

All patients eligible to participate in this study.

Device: Laser Speckle Contrast Imaging using the PerfusiX-Imaging device

Interventions

Laser Speckle Contrast Imaging using the PerfusiX-Imaging device DEVICE

Patient will undergo the standard-of-care gastric conduit procedure and in addition, peroperative Laser Speckle Contrast Imaging of the gastric conduit and eosophagus will be performed.

Group 1

Eligibility Criteria

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

Study Population

All patients meeting the eligibility criteria and scheduled to undergo esophageal resection in the Medical Center Leeuwarden.

You may qualify if:

• Scheduled to undergo esophageal resection;
• Age 18 years or older;
• Written informed consent;

You may not qualify if:

• \- Medical or psychiatric conditions that compromise the patient's ability to give informed consent;

Sponsors & Collaborators

• Frisius Medisch Centrum: lead
• University of Groningen: collaborator
• LIMIS Development: collaborator

Study Sites (1)

Medical Center Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

RECRUITING

Related Publications (19)

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• Heeman W, Dijkstra K, Hoff C, Koopal S, Pierie JP, Bouma H, Boerma EC. Application of laser speckle contrast imaging in laparoscopic surgery. Biomed Opt Express. 2019 Mar 25;10(4):2010-2019. doi: 10.1364/BOE.10.002010. eCollection 2019 Apr 1.

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• Milstein DMJ, Ince C, Gisbertz SS, Boateng KB, Geerts BF, Hollmann MW, van Berge Henegouwen MI, Veelo DP. Laser speckle contrast imaging identifies ischemic areas on gastric tube reconstructions following esophagectomy. Medicine (Baltimore). 2016 Jun;95(25):e3875. doi: 10.1097/MD.0000000000003875.

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• Kumagai Y, Ishiguro T, Haga N, Kuwabara K, Kawano T, Ishida H. Hemodynamics of the reconstructed gastric tube during esophagectomy: assessment of outcomes with indocyanine green fluorescence. World J Surg. 2014 Jan;38(1):138-43. doi: 10.1007/s00268-013-2237-9.

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MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• E.C. Boerma, MD/PhD

  Frisius Medisch Centrum

  PRINCIPAL INVESTIGATOR

Central Study Contacts

E.C. Boerma, MD/PhD

CONTACT

+31-58-2866738; boermachristiaan@gmail.com

J.P.E.N. Pierie, MD/PhD

CONTACT

+31-58-2866147; J.Pierie@MCL.nl

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: January 17, 2023
• Study Start: September 26, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: January 17, 2023

Record last verified: 2023-01

Locations

NL (1)