Use of Indocyanine Green in Acute Cholecystitis

NCT05709548 | Unknown Phase 4

• 1 other identifier: INDURGTRIAL2022
• Study Type: interventional
• Target: 440
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Indocyanine green

Outcome Measures

Primary Outcomes (1)

• operating time

  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 Outcomes (4)

• admission days

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

• intraoperative complications

  during surgical time

• postoperative morbidity

  in the first 30 days after surgery

• visualization of biliary anatomy with indocyanine green

  during surgical time

Study Arms (2)

control group

NO INTERVENTION

patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green

intervention group

ACTIVE COMPARATOR

Patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.

Drug: Indocyanine green

Interventions

Indocyanine green DRUG

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).

Also known as: indocyanine green group

intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (2)

Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

Hospital de Vic

Vic, Barcelona, . 08500, Spain

RECRUITING

Related Publications (8)

• 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.

  PMID: 34629815 BACKGROUND

• 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.

  PMID: 32936054 BACKGROUND

• 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.

  PMID: 34952715 BACKGROUND

• 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.

  PMID: 30614881 BACKGROUND

• 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.

  PMID: 33351457 BACKGROUND

• 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.

  PMID: 33052527 BACKGROUND

• 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.

  PMID: 27566635 BACKGROUND

• 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.

  PMID: 35241165 BACKGROUND

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Anna Muñoz Campaña, PhD

  Hospital Universitari Parc Taulí

  PRINCIPAL INVESTIGATOR

• Enrico Marrano

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Muñoz Campaña, PhD

CONTACT

003493 723 10 10; amunozc@tauli.cat

Coloma Moreno

CONTACT

003493 723 10 10; cmoreno@tauli.cat

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 2, 2023
• Study Start: March 15, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)