Study of the utility of Indocyanine Green Fluorescent Dye in Reducing Postoperative Complications in Minimally Invasive Surgery for Oesophageal Cancer

Effect of Fluorescent Imaging using Indocyanine Green on Surgical Morbidity during Minimally Invasive Surgery for Oesophageal Cancer (IndoCinMIE): A Phase2 Randomized Controlled Trial - IndoCinMIE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/09/058118

Enrollment

Registered

2023-09-29

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Health Condition 1: C159- Malignant neoplasm of esophagus, unspecified

Interventions

Intervention1: ICG: In the ICG-Group, Intraoperatively, during minimally invasive esophagectomy, the surgeons will check the conditions of the gastric conduit fashioned, such as the colour of the gast

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed resectable primary squamous cell carcinoma/adenocarcinoma of the oesophagus/GEJ candidates. 2. ECOG PS 0-2 fit to undergo radical surgery. 3. Patients with an informed consent to be included in the study.

Exclusion criteria

Exclusion criteria: 1. Patients who have undergone prior surgery for Oesophageal cancer. 2. Patients with a previous history of gastrointestinal or lung cancer, severe comorbidities, other organ distant metastasis, combined other organ resection. 3. Allergic hypersensitivity to ICG or iodine. 4. Patients not providing informed consent to participate in the study

Design outcomes

Primary

Measure	Time frame
To evaluate the efficacy of Indocyanine Green Dye use in the intraoperative period in minimally invasive esophagectomy, in decreasing the anastomotic leak rates after esophagectomy.Timepoint: 1 week & 4 weeks	—

Secondary

Measure	Time frame
To develop a standardized operative procedure of ICG use in oesophageal surgeries.Timepoint: on trial conclusion;To evaluate the operative time, blood loss, time until restoration of fluid diet, length of hospital stay, postoperative complications after the use of ICG fluorescence angiography during the intraoperative period of minimally invasive esophagectomy.Timepoint: 7 days;To study the use of ICG during minimally invasive esophagectomy in bringing about a change in surgical planning.Timepoint: at baseline	—

Measure

Time frame

To develop a standardized operative procedure of ICG use in oesophageal surgeries.Timepoint: on trial conclusion;To evaluate the operative time, blood loss, time until restoration of fluid diet, length of hospital stay, postoperative complications after the use of ICG fluorescence angiography during the intraoperative period of minimally invasive esophagectomy.Timepoint: 7 days;To study the use of ICG during minimally invasive esophagectomy in bringing about a change in surgical planning.Timepoint: at baseline

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Countries

India

Contacts

Public ContactAashish Kamatham

AIl India Institute of Medical Sciences, Jodhpur

drjvishnoi@gmail.com9455061569

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026