Application of the fluorescent dye 'indocyanine green': Does it improve the quality of surgery for patients with oesophageal and stomach cancer?

Not Applicable

Recruiting

• Conditions: Oesophageal cancer; Gastric cancer; Cancer - Oesophageal (gullet); Cancer - Stomach; Surgery - Surgical techniques

• Registration Number: ACTRN12624000015549
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-10
• Last Update Posted: 24 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Patients with cancers of the oesophagus, gastro-oesophageal junction and stomach who are undergoing curative-intent surgery.
2.Patients undergoing the following operations:
•Ivor-Lewis (two-stage) oesophagectomy
•McKeown (three-stage) oesophagectomy
•Proximal partial oesophago-gastrectomy
•Extended total gastrectomy
•Total gastrectomy
•Subtotal gastrectomy

Exclusion Criteria

1.Patient declined participation in study
2.Known allergy to indocyanine green, sodium iodide or iodine.
3.Evidence of thyroid nodules on physical examination or on standard of care staging PET/CT scan
4.Biochemical evidence of hyperthyroidism from thyroid function tests (TFT)
5.Patient’s receiving concurrent radioactive iodine treatment for thyroid disease
6.Patients with Stage IV cancer (AJCC 8th edition)
7.Stage IV and V kidney failure
8.Pregnancy and breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint for the study is whether there is difference in lymph node yield before and after the detection of ICG. [This will be determined by measuring the difference between the number of nodes identified in the surgical specimen and the extra nodes identified with ICG at the completion of surgical resection. The outcome will be assessed upon obtaining the final pathology report at 14 days post surgery (+/-7 days). ]

Secondary Outcome Measures

Name	Time	Method
Secondary outcome 1 is the metastasis detection rate within ICG LN (including Sensitivity and Specificity etc) .This will be determined by pathological analysis of lymph nodes that are labelled as ICG hot”. [Secondary outcome 1 will be determined by pathological analysis of the observed number of lymph nodes that are labelled as ICG hot vs. the number of lymph nodes that are not labelled as ICG hot as viewed with the infra-red camera The outcome will be assessed upon obtaining the final pathology report at 14 days post surgery (+/-7 days). ];Secondary outcome 2 is the detection rate of the ICG control node. The (positive) control node is defined as lymph node that is expected to fluouresce when ICG is injected peri-tumourally relative to the location of the tumour. [Secondary outcome 2 will be determined by the presence of fluroescence within the control node with the infra-red camera Secondary outcome 2 will be determined on the day of surgery]