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A THREE-GROUP RANDOMISED STUDY COMPARING: INJECTING ICG DYE INTO A VEIN, INSTILLING ICG DYE INTO THE GALLBLADDER, AND WITHOUT USING ICG DYE COMPARING WHICH IS BETTER IN IDENTIFYING IMPORTANT STRUCTURES DURING MINIMALLY INVASIVE GALLBLADDER REMOVAL SURGERY

THREE ARM RANDOMIZED TRIAL COMPARING INTRAVENOUS INDOCYANINE GREEN, INTRA GALL BLADDER INDOCYANINE GREEN AND NO INDOCYANINE GREEN DURING LAPAROSCOPIC CHOLECYSTECTOMY IN ACHIEVING CRITICAL VIEW OF SAFETY - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088526
Enrollment
102
Registered
2025-06-10
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Health Condition 1: K800- Calculus of gallbladder with acutecholecystitis Health Condition 2: K801- Calculus of gallbladder with othercholecystitis Health Condition 3: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Laparoscopic assisted cholecystectomy with intravenous ICG: Under GA, patient in reverse trendelenberg position with right side up , under all aseptic precautions parts painted and drap

Sponsors

Dr Asuri Krishna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with Ultrasound whole abdomen proved Gall stone disease who are hemodynamically stable and fit for General anaesthesia in whom Laparoscopic cholecystectomy is indicated either interval or immediate( within 72 hrs of presentation).

Exclusion criteria

Exclusion criteria: Patients who are planned for simultaneous common bile duct (CBD) exploration or have undergone previous failed Endoscopic retrograde cholangiopancreatography (ERCP) or have allergy to Indocyanine green (ICG)

Design outcomes

Primary

MeasureTime frame
Operative time from insertion of ports to achieving critical view of safety.Timepoint: Operative time from insertion of ports to achieving critical view of safety.

Secondary

MeasureTime frame
Blood lossTimepoint: Intraoperatively;Conversion to Subtotal cholecystectomyTimepoint: Intraoperatively;Conversion to open cholecystectomyTimepoint: Intraoperatively;Bile duct injuryTimepoint: Intraoperatively and in postoperative hospital stay;Post operative bile leakTimepoint: Postoperative hospital stay;Hospital stayTimepoint: Hospital stay

Countries

India

Contacts

Public ContactDr Nipun Chandra

All india institute of medical sciences, New delhi

dr.asurikrishna@gmail.com9051742097

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026