Use of Indocyanine Green in Acute Cholecystitis

Acute Cholecystitis Clinical Trial

— INDURG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05709548
• Other study ID #: INDURGTRIAL2022
• Status: Recruiting
• Phase: Phase 4
• Start date: March 15, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: Corporacion Parc Tauli
• Contact: Anna Muñoz Campaña, PhD
• Phone: 003493 723 10 10
• Email: amunozc[@]tauli.cat
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Bile Duct Injury
• Cholecystitis
• Cholecystitis, Acute

Intervention

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).

Locations

Country	Name	City	State
Spain	Hospital Universitari Parc Tauli	Sabadell	Barcelona
Spain	Hospital de Vic	Vic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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