Use of Indocyanine Green in Acute Cholecystitis (INDURG)

September 27, 2023 updated by: Anna Muñoz - Campaña, Corporacion Parc Tauli

INDURG TRIAL: A Randomized Controlled Trial Using Indocyanine Green During Cholecystectomy in Acute Cholecystitis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective, controlled, randomized and multicenter clinical trial comparing conventional laparoscopic cholecystectomy versus laparoscopic cholecystectomy with preoperative indocyanine green administration in patients with an indication for urgent cholecystectomy due to acute cholecystitis (of any etiology), at the Parc Taulí University Hospital and at the Germans Trias i Pujol University Hospital.

Parallel group randomization (1:1) will be performed by opening sealed envelopes, with random assignment between the two groups (intervention and control). The same number of envelopes will be assigned to the study and control group, all of them sealed and placed at random.

A four-port laparoscopic cholecystectomy will be performed by a team of surgeons with extensive experience in emergency and/or hepatobiliopancreatic surgery, according to standard techniques and safety measures.

Randomization will be carried out at the time of the indication for surgery, after acceptance and signing of the informed consent once all the inclusion criteria are met.

Study Type

Interventional

Enrollment (Estimated)

440

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Anna Muñoz Campaña, PhD
  • Phone Number: 80614 003493 723 10 10
  • Email: amunozc@tauli.cat

Study Contact Backup

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Taulí
        • Contact:
          • ANNA MUÑOZ-CAMPAÑA, PhD
          • Phone Number: 80614 003493 723 10 10
          • Email: amunozc@tauli.cat
        • Contact:
      • Vic, Barcelona, Spain, . 08500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with an indication for urgent laparoscopic cholecystectomy due to acute cholecystitis regardless of its etiology.
  • Age over 18 years.
  • Patients who have read the study information sheet and signed the informed consent sheet.

Exclusion Criteria:

  • Pregnant or breastfeeding patients.
  • Grade IV renal failure or patients on dialysis
  • Patients with previous hypersensitivity to indocyanine green
  • Patients with allergy to iodinated contrast
  • Patients with clinical hyperthyroidism, autonomic thyroid adenomas, and focal and diffuse autonomic abnormalities of the thyroid gland
  • Contraindication to laparoscopic surgery.
  • Suspicion of choledocholithiasis
  • Pediatric patients under 18 years of age.
  • Patients who refused to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green
Active Comparator: intervention group
Patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.
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).
Other Names:
  • indocyanine green group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operating time
Time Frame: from the beginning of the surgery to its end, up to 300 minutes
time between the start of the surgical incision and the end of surgery
from the beginning of the surgery to its end, up to 300 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
admission days
Time Frame: length of hospital stay, from admission to discharge, up to 3 month
days of hospital admission
length of hospital stay, from admission to discharge, up to 3 month
intraoperative complications
Time Frame: during surgical time
surgical injuries during surgery
during surgical time
postoperative morbidity
Time Frame: in the first 30 days after surgery
complications evidenced in the postoperative period
in the first 30 days after surgery
visualization of biliary anatomy with indocyanine green
Time Frame: during surgical time
Evidence the correct visualization of the biliary structures after the administration of indocyanine green
during surgical time

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Anna Muñoz Campaña, PhD, Hospital Universitari Parc Taulí
  • Principal Investigator: Enrico Marrano, Germans Trias i Pujol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2023

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 30, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

September 29, 2023

Last Update Submitted That Met QC Criteria

September 27, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INDURGTRIAL2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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