THE ROLE OF INDOCYANINE GREEN FLUORESCENCE IMAGING IN OESOPHAGEAL CANCER SURGERIES TO ASSESS ANASTOMOTIC SITES DURING SURGERY
Phase 3
Completed
- Conditions
- Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified
- Registration Number
- CTRI/2022/05/042805
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 78
Inclusion Criteria
1.Age – 18-85 years
2.Biopsy proven cancers of oesophagus involving the middle, distal 1/3rd and GE junction tumors planned for Curative Resection procedures (Ivor Lewis oesophagectomy/McKeown oesophagectomy/Orringer oesophagectomy)
3.Patient fit for major surgery
Exclusion Criteria
1.Recurrent oesophageal cancers
2.Non resectable cancers
3.Any past history of extensive surgery in the mediastinum, neck or stomach which might have resulted in the disruption of arteriovenous and lymphatic system.
4.Patient not fit for surgery
5.Metastatic carcinoma oesophagus
6.Patients not giving consent for participation in this study
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the anastomotic leak rates after intraoperative perfusion assessment of gastric or colonic conduits with ICG dye <br/ ><br>Timepoint: Immediately after surgery till 5th post operative day <br/ ><br>
- Secondary Outcome Measures
Name Time Method 2.Establishing the ideal time for intraoperative assessment of vascularity after injection of ICG dyeTimepoint: Intraoperative assessment;2.To determine the difference in qualitative assessment of gastric/colonic conduit vascularity by visual inspection and by ICG fluorescence imagingTimepoint: Intraoperative assessment;To assess the conduit margin revision rates with ICG fluorescence imaging at the proposed anastomotic site compared to visual assessment.Timepoint: Intraoperative assessment <br/ ><br>