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A Study of Special Green Dye Imaging to Reduce Leakage After Keyhole Surgery for Food Pipe Cancer

A Prospective Randomized Controlled Trial Evaluating Indocyanine Green Fluorescence Imaging for Reducing Anastomotic Leak Rates in McKeown Minimally Invasive Esophagectomy - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/107007
Enrollment
168
Registered
2026-03-27
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: ICG group: Patients in the intervention group will undergo McKeown minimally invasive esophagectomy with intraoperative indocyanine green (ICG) fluorescence imaging to assess gastric co

Sponsors

Basavatarakam Indo American Cancer Hospital and Research Institute
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients 18 years to 75 years. Histologically confirmed carcinoma of the esophagus or gastroesophageal junction. Patients planned for McKeown minimally invasive esophagectomy with gastric conduit reconstruction and cervical esophagogastric anastomosis. Patients who may have received neoadjuvant chemotherapy or chemoradiotherapy as per institutional protocol. Resectable disease without distant metastasis on preoperative staging. Ability to provide written informed consent.

Exclusion criteria

Exclusion criteria: Refusal or inability to provide informed consent. Unresectable or metastatic disease detected during preoperative evaluation or intraoperatively. Patients considered high risk for esophagectomy due to severe cardiopulmonary comorbidity. Known allergy or hypersensitivity to indocyanine green or iodine. Pregnant or breastfeeding women. Severe renal or hepatic dysfunction contraindicating ICG use.

Design outcomes

Primary

MeasureTime frame
Incidence of anastomotic leak within 30 days after McKeown minimally invasive esophagectomy.Timepoint: Within 30 days postoperatively.

Secondary

MeasureTime frame
Perfusion assessment of gastric conduit and proximal esophageal stump using ICG fluorescence imaging compared with visual assessment.Timepoint: ;Rate of intraoperative modification of the anastomotic site based on perfusion findingsTimepoint: ;Time to fluorescence appearance and complete conduit enhancement after intravenous ICG injectionTimepoint: ;Postoperative morbidity within 30 days according to Clavein Dindo scaleTimepoint: Within 30 days postoperatively;Length of postoperative hospital stay (days)Timepoint: ;30-day postoperative mortalityTimepoint:

Countries

India

Contacts

Public ContactSyed Nusrath

Basavatarakam Indo American Cancer Hospital and Research Institute

dr.nusrath2008@gmail.com9030747486

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026