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Efficacy of Fluorescence Navigation in Complicated Extrahepatic Cholelithiasis Surgery

Efficacy of Fluorescence Navigation in Complicated Extrahepatic Cholelithiasis Surgery:A Two-center Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400088163
Enrollment
Unknown
Registered
2024-08-13
Start date
2024-10-01
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

extrahepatic cholelithiasis

Interventions

Group A(ICG group):Performing laparoscopic cholecystectomy (with or without transcystic common bile duct exploration) under fluorescence mode.
Group B(white-light group):Performing laparoscopic cholecystectomy (with or without transcystic common bile duct exploration) under conventional white light mode.

Sponsors

Department of Hepatobiliary Surgery and Liver Transplantation, The Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1: Meeting the criteria for complicated extrahepatic cholelithiasis: gallbladder wall edema thickening =4mm; gangrenous cholecystitis with or without perforation; with history of upper abdominal surgery; impacted stones in the gallbladder neck, Mirizzi syndrome or variation of extrahepatic bile duct; requiring transcystic common bile duct exploration; 2: Patients who are in generally good condition and able to tolerate the surgery; 3: Patients who are over 18 years old, under 80 years old, with no gender restrictions; 4: Patients who agree to sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1: Patients who are pregnant or lactating; 2: Patients with pathological results indicating malignancy; 3: Patients allergic to ICG; 4: Researchers believe that subjects may not necessarily complete this study or adhere to its requirements (due to logistical or other reasons).

Design outcomes

Primary

MeasureTime frame
Identification of calot's triangle;Identification of extrahepatic bile ducts;Incidence of bile duct injury;

Secondary

MeasureTime frame
Time for identifying the Calot's triangle;Time for identifying the CD and CBD junction;Identification of cystic artery;Duration of surgery;Postoperative complications;

Countries

China

Contacts

Public ContactBaojia Zou

The Fifth Affiliated Hospital of Sun Yat-sen University

zoubj6@mail.sysu.edu.cn+86 132 6798 0325

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 5, 2026