Assessment of Graft Perfusion and Oxygenation for Improved Outcome in Esophageal Cancer Surgery

NCT03587532 | Unknown DMC

• 1 other identifier: EC/2018/0671
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

After the esophagectomy, the stomach is most commonly used to restore continuity of the upper gastro-intestinal tract. The esophagogastric anastomosis is prone to serious complications such as anastomotic leakage (AL) The reported incidence of AL after esophagectomy ranges from 5%-20%. The AL associated mortality ranges from 18-40% compared with an overall in-hospital mortality of 4-6%. The main cause of AL is tissue hypoxia, which results from impaired perfusion of the pedicle stomach graft. Clinical judgment is unreliable in determining anastomotic perfusion. Therefore, an objective, validated, and reproducible method to evaluate tissue perfusion at the anastomotic site is urgently needed. Indocyanine green angiography (ICGA) is a near infrared fluorescent (NIRF) perfusion imaging using indocyanine green (ICG). ICGA is a safe, easy and reproducible method for graft perfusion analysis, but it is not yet calibrated. The purpose of this study is to evaluate the feasibility of quantification of ICGA to assess graft perfusion and its influence on AL in patients after minimally invasive Ivor Lewis esophagectomy (MIE) for cancer.

Conditions

Anastomotic Leak; Esophageal Cancer

Keywords

esophagectomy; indocyanine green; near infrared fluorescence

Outcome Measures

Primary Outcomes (1)

• An ICGA based cutoff point to predict anastomotic leakage and graft necrosis after esophageal reconstructive surgery.

  quantitative analysis of the ICGA images. T inflow will be calculated based on time fluorescence curves, and correlated with anastomotic leakage and graft necrosis. This cutoff value will be an ICGA fluorescent intensity time measurement expressed in seconds.

  within 3 months after intervention

Secondary Outcomes (14)

• The evaluation of ICGA as a quantitative perfusion imaging modality during gastric tube reconstruction.

  within 3 months after intervention

• Systemic lactate as a Biological Markers of hypoxia and ischemia

  within 24 hours after intervention

• Capillary lactate as a Biological Markers of hypoxia and ischemia

  within 24 hours after intervention

• Basal oxygen consumption (V0) as a Biological Markers of hypoxia and ischemia

  within 24 hours after intervention

• Max respiratory oxygen consumption (Vmax) as a Biological Markers of hypoxia and ischemia

  within 24 hours after intervention

Study Arms (1)

Indocyanine Green Angiography

EXPERIMENTAL

ICG based angiography after creation of the stomach graft and after thoracic pull-up of the graft. Dynamic digital images will be obtained starting immediately after intravenous bolus administration of 0.5 mg/kg of ICG.

Diagnostic Test: Indocyanine green angiography; Diagnostic Test: Hemodynamic evaluation; Diagnostic Test: Biological and pathological markers of ischemia

Interventions

Indocyanine green angiography DIAGNOSTIC_TEST

ICGA will be performed twice during standard esophagectomy: 30 minutes after the stomach graft creation and immediately before the esophagogastric anastomosis. stock dose of 25 mg ICG (Pulsion Medical Systems, Germany) will be diluted to 5 mg/mL with sterile water. An IV bolus of 0.5 mg/kg of ICG will be injected via a central venous catheter. Video data will be obtained with a charge-coupled device (CCD) camera fitted with a light-emitting diode emitting at a wavelength of 760mm (Visera® elite II, Olympus medical system corp, Tokyo, Japan). Images will be recorded starting immediately prior to injection until 3 minutes afterwards.

Also known as: near infrared fluorescent imaging

Indocyanine Green Angiography

Hemodynamic evaluation DIAGNOSTIC_TEST

Advanced continuous hemodynamic monitoring during surgery will be performed using a PiCCO® (Pulse index Continuous Cardiac Output, Pulsion Medical Systems, Germany) catheter.

Indocyanine Green Angiography

Biological and pathological markers of ischemia DIAGNOSTIC_TEST

* Systemic and local capillary lactate on blood samples * Mitochondrial Respiratory activity analyses on biopsies at 3 region of interest (ROI) * Pathological analyses of the biopsies at 3 ROI

Indocyanine Green Angiography

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre- and intraoperatively
• Subjects ≥ 18 years and ≤ 75 years who are willing to participate and provide written informed consent prior to any study-related procedures.
• Subjects scheduled for elective minimally invasive Ivor Lewis esophagectomy
• Intrathoracic circular stapled esophago-gastric anastomosis

You may not qualify if:

• Preoperatively
• Known hypersensitivity to ICG
• Female patients who are pregnant or nursing
• Participation in other studies involving investigational drugs or devices.
• Use of Avastin™ (bevacizumab) or other anti vascular endothelial growth factor (VEGF) agents within 30 days prior to surgery
• Intra-operatively
• Intra-operative findings that may preclude conduct of the study procedures
• Anastomosis performed differently than the standard of care
• Excessive bleeding (\>500 ml) prior to anastomosis

Sponsors & Collaborators

• University Hospital, Ghent: lead
• Kom Op Tegen Kanker: collaborator

Study Sites (1)

University Hospital

Ghent, 9000, Belgium

RECRUITING

Related Publications (25)

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• Van Daele E, Van Nieuwenhove Y, Ceelen W, Vanhove C, Braeckman BP, Hoorens A, Van Limmen J, Varin O, Van de Putte D, Willaert W, Pattyn P. Assessment of graft perfusion and oxygenation for improved outcome in esophageal cancer surgery: Protocol for a single-center prospective observational study. Medicine (Baltimore). 2018 Sep;97(38):e12073. doi: 10.1097/MD.0000000000012073.

  PMID: 30235661 DERIVED

Related Links

• Cancer Statistics, GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence Worldwide in 2012. International Agency for Research on Cancer, WHO.

MeSH Terms

Conditions

Anastomotic Leak; Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Yves Yves.Vannieuwenhove@uzgent.be, MD, PhD

  University Hospital, Ghent

  STUDY DIRECTOR

Central Study Contacts

Elke Van Daele, MD

CONTACT

+323320829; elke.vandaele@uzgent.be

Yves Van Nieuwenhove, MD, PhD

CONTACT

+3293324893; Yves.Vannieuwenhove@uzgent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: July 16, 2018
• Study Start: December 13, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 28, 2023

Record last verified: 2023-12

Locations

BE (1)