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Use of Indocyanine Green in Acute Cholecystitis

NCT05709548 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 440

Last updated 2023-09-29

No results posted yet for this study

Summary

Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries. However, it can be technically complex in those patients diagnosed with acute cholecystitis who present severe inflammation or fibrosis, with bile duct injury being one of its main complications. The use of fluorescence cholangiography through the use of indocyanine green allows the identification of extrahepatic biliary structures, facilitating dissection and reducing the risk of bile duct lesions. Better visualization of the bile duct allows reducing the conversion rate to open surgery, as well as operating time.

The main objective is to assess a decrease in operating time in acute cholecystitis undergoing emergency surgery, to which indocyanine green is administered preoperatively.

Randomized, prospective, controlled, multicenter clinical trial of two groups of patients diagnosed with acute cholecystitis and requiring urgent cholecystectomy. The control group includes 220 patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green, and the intervention group includes 220 patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.

Study led by the Parc Taulí University Hospital in Sabadell.

Conditions

  • Acute Cholecystitis
  • Bile Duct Injury

Interventions

DRUG

Indocyanine green

Subjects with a diagnosis of acute cholecystitis who undergo urgent laparoscopic cholecystectomy with the preoperative administration of indocyanine green (between 1-2 hours prior to surgery).

Sponsors & Collaborators

  • Corporacion Parc Tauli

    lead OTHER

Principal Investigators

  • Anna Muñoz Campaña, PhD · Hospital Universitari Parc Taulí

  • Enrico Marrano · Germans Trias i Pujol Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-15
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05709548 on ClinicalTrials.gov