Clinical trial · Interventional
Assessment of Graft Perfusion and Oxygenation for Improved Outcome in Esophageal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biological and pathological markers of ischemia | Diagnostic Test | — | UNRESOLVED |
| Hemodynamic evaluation | Diagnostic Test | — | UNRESOLVED |
| Indocyanine green angiography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Indocyanine Green Angiography
- description
- 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.
- interventionNames
- Diagnostic Test: Indocyanine green angiography
- Diagnostic Test: Hemodynamic evaluation
- Diagnostic Test: Biological and pathological markers of ischemia
Primary outcomes (1)
- measure
- An ICGA based cutoff point to predict anastomotic leakage and graft necrosis after esophageal reconstructive surgery.
- timeFrame
- within 3 months after intervention
- description
- 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.
Secondary outcomes (14)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 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 Exclusion Criteria: 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
References
Publications (25)
- BACKGROUNDKassis ES, Kosinski AS, Ross P Jr, Koppes KE, Donahue JM, Daniel VC. Predictors of anastomotic leak after esophagectomy: an analysis of the society of thoracic surgeons general thoracic database. Ann Thorac Surg. 2013 Dec;96(6):1919-26. doi: 10.1016/j.athoracsur.2013.07.119. Epub 2013 Sep 24. PMID 24075499
- BACKGROUNDBiere SS, Maas KW, Cuesta MA, van der Peet DL. Cervical or thoracic anastomosis after esophagectomy for cancer: a systematic review and meta-analysis. Dig Surg. 2011;28(1):29-35. doi: 10.1159/000322014. Epub 2011 Feb 4. PMID 21293129
- BACKGROUNDSauvanet A, Mariette C, Thomas P, Lozac'h P, Segol P, Tiret E, Delpero JR, Collet D, Leborgne J, Pradere B, Bourgeon A, Triboulet JP. Mortality and morbidity after resection for adenocarcinoma of the gastroesophageal junction: predictive factors. J Am Coll Surg. 2005 Aug;201(2):253-62. doi: 10.1016/j.jamcollsurg.2005.02.002. PMID 16038824
- BACKGROUNDSunpaweravong S, Ruangsin S, Laohawiriyakamol S, Mahattanobon S, Geater A. Prediction of major postoperative complications and survival for locally advanced esophageal carcinoma patients. Asian J Surg. 2012 Jul;35(3):104-9. doi: 10.1016/j.asjsur.2012.04.029. Epub 2012 Jun 6. PMID 22884266
- BACKGROUNDHaga Y, Wada Y, Takeuchi H, Ikejiri K, Ikenaga M. Prediction of anastomotic leak and its prognosis in digestive surgery. World J Surg. 2011 Apr;35(4):716-22. doi: 10.1007/s00268-010-0922-5. PMID 21184072
- BACKGROUNDRutegard M, Lagergren P, Rouvelas I, Lagergren J. Intrathoracic anastomotic leakage and mortality after esophageal cancer resection: a population-based study. Ann Surg Oncol. 2012 Jan;19(1):99-103. doi: 10.1245/s10434-011-1926-6. Epub 2011 Jul 19. PMID 21769467
- BACKGROUNDVan Daele E, Van de Putte D, Ceelen W, Van Nieuwenhove Y, Pattyn P. Risk factors and consequences of anastomotic leakage after Ivor Lewis oesophagectomydagger. Interact Cardiovasc Thorac Surg. 2016 Jan;22(1):32-7. doi: 10.1093/icvts/ivv276. Epub 2015 Oct 3.