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Acute CholecystitisPhase 4INDURGNCT05709548

Use of Indocyanine Green in Acute Cholecystitis

A Phase 4 study testing Indocyanine green in people with Acute Cholecystitis and Bile Duct Injury, run by Corporacion Parc Tauli at 2 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Acute Cholecystitis, Bile Duct Injury
What is being tested?
Indocyanine green
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
2 sitesSpain
Study dates
15 Mar 2023to Dec 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Suspicion of choledocholithiasis
  • Pediatric patients under 18 years of age.
  • Patients who refused to participate in the study

Trial locations and contacts

2 sites in 1 country.

Anna Muñoz Campaña, PhD contact

003493 723 10 10 ext. 80614

amunozc@tauli.cat

Coloma Moreno contact

003493 723 10 10 ext. 22219

cmoreno@tauli.cat

Spain2 sites, 2 recruiting

  • Hospital Universitari Parc Tauli

    Sabadell, Barcelona, 08208

    ANNA MUÑOZ-CAMPAÑA, PhD, 003493 723 10 10 ext. 80614, amunozc@tauli.cat

    ENRICO MARRANO, 0034934 65 12 00, enrico.marrano@gmail.com

    Recruiting

  • Hospital de Vic

    Vic, Barcelona, . 08500

    VICTORIA LUCAS GUERRERO, Dr, victorialucasg@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: 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.

Read more

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.

Read the 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.

Being tested
Indocyanine green
Keywords
Indocyanine green
Medical subject headings
Cholecystitis, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine greenDrug

    Also called indocyanine green group

    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).

Study groups in NCT05709548
Study groupRoleWhat they receive
control groupNo interventionpatients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green
intervention groupActive comparatorPatients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.
Receives: Drug: Indocyanine green

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operating time

    time between the start of the surgical incision and the end of surgery

    Measured: from the beginning of the surgery to its end, up to 300 minutes

Secondary outcomes (4)

  1. admission days

    days of hospital admission

    Measured: length of hospital stay, from admission to discharge, up to 3 month

  2. intraoperative complications

    surgical injuries during surgery

    Measured: during surgical time

  3. postoperative morbidity

    complications evidenced in the postoperative period

    Measured: in the first 30 days after surgery

  4. visualization of biliary anatomy with indocyanine green

    Evidence the correct visualization of the biliary structures after the administration of indocyanine green

    Measured: during surgical time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2023
  2. Study start15 Mar 2023
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05709548
Sponsor's protocol ID
INDURGTRIAL2022
Acronym
INDURG
Status last verified
Sep 2023
First submitted
12 Jan 2023
Last updated
29 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pesce A, Piccolo G, Lecchi F, Fabbri N, Diana M, Feo CV. Fluorescent cholangiography: An up-to-date overview twelve years after the first clinical application. World J Gastroenterol. 2021 Sep 28;27(36):5989-6003. doi: 10.3748/wjg.v27.i36.5989.

    PubMed 34629815

  • Di Maggio F, Hossain N, De Zanna A, Husain D, Bonomo L. Near-Infrared Fluorescence Cholangiography can be a Useful Adjunct during Emergency Cholecystectomies. Surg Innov. 2022 Aug;29(4):526-531. doi: 10.1177/1553350620958562. Epub 2020 Sep 16.

    PubMed 32936054

  • Reeves JJ, Broderick RC, Lee AM, Blitzer RR, Waterman RS, Cheverie JN, Jacobsen GR, Sandler BJ, Bouvet M, Doucet J, Murphy JD, Horgan S. The price is right: Routine fluorescent cholangiography during laparoscopic cholecystectomy. Surgery. 2022 May;171(5):1168-1176. doi: 10.1016/j.surg.2021.09.027. Epub 2021 Dec 21.

    PubMed 34952715

  • Dip F, LoMenzo E, Sarotto L, Phillips E, Todeschini H, Nahmod M, Alle L, Schneider S, Kaja L, Boni L, Ferraina P, Carus T, Kokudo N, Ishizawa T, Walsh M, Simpfendorfer C, Mayank R, White K, Rosenthal RJ. Randomized Trial of Near-infrared Incisionless Fluorescent Cholangiography. Ann Surg. 2019 Dec;270(6):992-999. doi: 10.1097/SLA.0000000000003178.

    PubMed 30614881

  • Wang X, Teh CSC, Ishizawa T, Aoki T, Cavallucci D, Lee SY, Panganiban KM, Perini MV, Shah SR, Wang H, Xu Y, Suh KS, Kokudo N. Consensus Guidelines for the Use of Fluorescence Imaging in Hepatobiliary Surgery. Ann Surg. 2021 Jul 1;274(1):97-106. doi: 10.1097/SLA.0000000000004718.

    PubMed 33351457

  • Broderick RC, Lee AM, Cheverie JN, Zhao B, Blitzer RR, Patel RJ, Soltero S, Sandler BJ, Jacobsen GR, Doucet JJ, Horgan S. Fluorescent cholangiography significantly improves patient outcomes for laparoscopic cholecystectomy. Surg Endosc. 2021 Oct;35(10):5729-5739. doi: 10.1007/s00464-020-08045-x. Epub 2020 Oct 14.

    PubMed 33052527

  • van den Bos J, Schols RM, Luyer MD, van Dam RM, Vahrmeijer AL, Meijerink WJ, Gobardhan PD, van Dam GM, Bouvy ND, Stassen LP. Near-infrared fluorescence cholangiography assisted laparoscopic cholecystectomy versus conventional laparoscopic cholecystectomy (FALCON trial): study protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Aug 26;6(8):e011668. doi: 10.1136/bmjopen-2016-011668.

    PubMed 27566635

  • Pavel MC, Boira MA, Bashir Y, Memba R, Llacer E, Estalella L, Julia E, Conlon KC, Jorba R. Near infrared indocyanine green fluorescent cholangiography versus intraoperative cholangiography to improve safety in laparoscopic cholecystectomy for gallstone disease-a systematic review protocol. Syst Rev. 2022 Mar 3;11(1):36. doi: 10.1186/s13643-022-01907-6.

    PubMed 35241165

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indocyanine green in people with Acute Cholecystitis and Bile Duct Injury, run by Corporacion Parc Tauli at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Anna Muñoz Campaña, PhD (003493 723 10 10 ext. 80614, amunozc@tauli.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operating time (time frame: from the beginning of the surgery to its end, up to 300 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05709548, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2023.

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