Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
440 participants
INTERVENTIONAL
2023-03-15
2025-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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control group
patients who undergo urgent laparoscopic cholecystectomy according to the usual technique without the administration of indocyanine green
No interventions assigned to this group
intervention group
Patients who undergo urgent laparoscopic cholecystectomy for acute cholecystitis with the administration of indocyanine green preoperatively.
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age over 18 years.
* Patients who have read the study information sheet and signed the informed consent sheet.
Exclusion Criteria
* 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
18 Years
100 Years
ALL
No
Sponsors
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Corporacion Parc Tauli
OTHER
Responsible Party
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Anna Muñoz - Campaña
Principal investigator
Principal Investigators
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Anna Muñoz Campaña, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari Parc Taulí
Enrico Marrano
Role: PRINCIPAL_INVESTIGATOR
Germans Trias i Pujol Hospital
Locations
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Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain
Hospital de Vic
Vic, Barcelona, Spain
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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INDURGTRIAL2022
Identifier Type: -
Identifier Source: org_study_id
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