Predictive Factors Associated to Bile Cultures and Antibiogram Resistance in Patients With Laparoscopic Cholecystectomy

Antibiotic Resistant Strain Clinical Trial

— BACILO  

Official title:

Predictive Factors Associated With Bile Culture Positivity And phenotypiCal antIbiogram Resistance Patterns in Patients Taken to LaparOscopic Cholecystectomy (BACILO): A Protocol for a Prediction Model Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06314399
• Other study ID #: 2023-18
• Secondary ID: DVO005 2555-CV18
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Hospital Universitario Mayor Méderi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The BACILO study was designed with the objective of having robust data on local epidemiological bacterial colonisation information on bile cultures with patients taken to laparoscopic cholecystectomy in our institution to find which predictive factors are associated with culture positivity and antibiotic resistance patterns. Secondary endpoints include evaluating demographical, clinical and surgical variables and establishing comparison between both positive and negative bile cultures and between antibiotic sensitive and resistant microorganism strain isolations.

Description:

BACILO is single-centre, observational, analytical, prospective study with a prognostic prediction model with the objective of identifying predictive factors associated with microbial and antibiotic resistance patterns in bile cultures of patients taken to laparoscopic cholecystectomy in our institution. Primary outcomes are bile culture positivity and phenotypical resistance antibiogram patterns while secondary outcomes include demographic, clinical and surgical characteristics and surgical outcomes. The main objective is to determine predictive factors using a prediction model, variables included are: Age, diabetes mellitus, C-reactive protein test, choledocholithiasis/ERCP, cholecystitis and severity of cholecystitis according to the 2018 Tokyo guidelines.This in the nature of describing the relationship between bile culture positivity and phenotypical antibiogram resistance patterns in our institution, and establish thus better treatment strategies based on higher quality local evidence.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 703
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients included must be over 18 years of age and be taken to laparoscopic cholecystectomy between March 2024 and February 2026 in any institution of the Méderi hospital network (Hospital Universitario Mayor and Hospital Universitario Barrios Unidos), have signed the written informed consent to be included in the study and have both bile culture and antibiogram.

Exclusion Criteria:

• - Patients that will be taken to laparoscopic cholecystectomy with another concomitant surgical procedure (including but not exclusive to gastrectomy, pancreatoduodenectomy, oesophagectomy, splenectomy, abdominal wall reconstruction, colectomy, amongst others) with the exception of umbilical herniorrhaphy.
• Patients without a postoperative control appointment.
• Patients with an untreated HIV diagnosis.
• Patients with diagnosis of a malignant gallbladder or biliary tract disease documented preoperatively.

Related Conditions & MeSH terms

• Antibiotic Resistant Strain
• Biliary Infection
• Infections

Intervention

Diagnostic Test:
• Bile culture and phenotypic antibiogram resistance test
Extraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Mayor Méderi	Universidad del Rosario

References & Publications (12)

Dyrhovden R, Ovrebo KK, Nordahl MV, Nygaard RM, Ulvestad E, Kommedal O. Bacteria and fungi in acute cholecystitis. A prospective study comparing next generation sequencing to culture. J Infect. 2020 Jan;80(1):16-23. doi: 10.1016/j.jinf.2019.09.015. Epub 2019 Oct 2. — View Citation

Galili O, Eldar S Jr, Matter I, Madi H, Brodsky A, Galis I, Eldar S Sr. The effect of bactibilia on the course and outcome of laparoscopic cholecystectomy. Eur J Clin Microbiol Infect Dis. 2008 Sep;27(9):797-803. doi: 10.1007/s10096-008-0504-8. Epub 2008 Mar 28. — View Citation

Gomi H, Solomkin JS, Schlossberg D, Okamoto K, Takada T, Strasberg SM, Ukai T, Endo I, Iwashita Y, Hibi T, Pitt HA, Matsunaga N, Takamori Y, Umezawa A, Asai K, Suzuki K, Han HS, Hwang TL, Mori Y, Yoon YS, Huang WS, Belli G, Dervenis C, Yokoe M, Kiriyama S, Itoi T, Jagannath P, Garden OJ, Miura F, de Santibanes E, Shikata S, Noguchi Y, Wada K, Honda G, Supe AN, Yoshida M, Mayumi T, Gouma DJ, Deziel DJ, Liau KH, Chen MF, Liu KH, Su CH, Chan ACW, Yoon DS, Choi IS, Jonas E, Chen XP, Fan ST, Ker CG, Gimenez ME, Kitano S, Inomata M, Mukai S, Higuchi R, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: antimicrobial therapy for acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):3-16. doi: 10.1002/jhbp.518. Epub 2018 Jan 9. — View Citation

Jang DK, Kim J, Park WB, Yi SY, Lee JK, Yoon WJ. Increasing burden of biliary tract infection caused by extended-spectrum beta-lactamase-producing organisms in Korea: A nationwide population-based study. J Gastroenterol Hepatol. 2020 Jan;35(1):56-64. doi: 10.1111/jgh.14809. Epub 2019 Aug 13. — View Citation

Kaplan U, Handler C, Chazan B, Weiner N, Hatoum OA, Yanovskay A, Kopelman D. The Bacteriology of Acute Cholecystitis: Comparison of Bile Cultures and Clinical Outcomes in Diabetic and Non-Diabetic Patients. World J Surg. 2021 Aug;45(8):2426-2431. doi: 10.1007/s00268-021-06107-2. Epub 2021 Apr 15. — View Citation

Lee JM, Kang JS, Choi YJ, Byun Y, Jin SH, Yoon KC, Lee HW, Jang JY, Lim CS. Suggested use of empirical antibiotics in acute cholecystitis based on bile microbiology and antibiotic susceptibility. HPB (Oxford). 2023 May;25(5):568-576. doi: 10.1016/j.hpb.2023.01.017. Epub 2023 Feb 3. — View Citation

Manrai M, Jha AA, Singh Shergill SP, Thareja S, Sood AK, Shukla R, Jain R, Dhiman P, Gaurab. Microbiology of bile in extrahepatic biliary obstruction: A tropical experience. Indian J Med Microbiol. 2021 Jan;39(1):54-58. doi: 10.1016/j.ijmmb.2020.10.002. Epub 2020 Dec 4. — View Citation

Pisano M, Allievi N, Gurusamy K, Borzellino G, Cimbanassi S, Boerna D, Coccolini F, Tufo A, Di Martino M, Leung J, Sartelli M, Ceresoli M, Maier RV, Poiasina E, De Angelis N, Magnone S, Fugazzola P, Paolillo C, Coimbra R, Di Saverio S, De Simone B, Weber DG, Sakakushev BE, Lucianetti A, Kirkpatrick AW, Fraga GP, Wani I, Biffl WL, Chiara O, Abu-Zidan F, Moore EE, Leppaniemi A, Kluger Y, Catena F, Ansaloni L. 2020 World Society of Emergency Surgery updated guidelines for the diagnosis and treatment of acute calculus cholecystitis. World J Emerg Surg. 2020 Nov 5;15(1):61. doi: 10.1186/s13017-020-00336-x. — View Citation

Shafagh S, Rohani SH, Hajian A. Biliary infection; distribution of species and antibiogram study. Ann Med Surg (Lond). 2021 Sep 7;70:102822. doi: 10.1016/j.amsu.2021.102822. eCollection 2021 Oct. — View Citation

van der Linden YT, Bosscha K, Prins HA, Lips DJ. Single-port laparoscopic cholecystectomy vs standard laparoscopic cholecystectomy: A non-randomized, age-matched single center trial. World J Gastrointest Surg. 2015 Aug 27;7(8):145-51. doi: 10.4240/wjgs.v7.i8.145. — View Citation

Wu ZY, Wu XS, Yao WY, Wang XF, Quan ZW, Gong W. [Pathogens' distribution and changes of antimicrobial resistance in the bile of acute biliary tract infection patients]. Zhonghua Wai Ke Za Zhi. 2021 Jan 1;59(1):24-31. doi: 10.3760/cma.j.cn112139-20200717-00559. Chinese. — View Citation

Yoon JH, Paik KY, Chung HY, Oh JS. Clinical implication of bactibilia in moderate to severe acute cholecystitis undergone cholecystostomy following cholecystectomy. Sci Rep. 2021 Jun 4;11(1):11864. doi: 10.1038/s41598-021-91261-9. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bile culture positivity	Bile culture is tested positive for at least one (1) microorganism	Perioperatively, during the procedure and immediately after the intervention
Primary	Phenotypical antibiogram resistance	If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity	Perioperatively, during the procedure and immediately after the intervention
Secondary	Microbial characteristics	To describe the microbial characteristics of the bile cultures and their phenotypical antibiogram resistance	Immediately after the intervention
Secondary	Bile culture and antibiotic resistance relationship	Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes	Immediately after the intervention
Secondary	Demographical and clinical characteristics	To describe and compare the demographic and clinical characteristics of the study population.	Pre-intervention
Secondary	Surgical characteristics and outcomes	To describe and compare the surgical characteristics and outcomes of the study population	During the 15 day postoperative follow-up appointment
Secondary	Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis)	To determine demographic and clinical predictive factors for positive bile cultures and phenotypical antibiogram resistance.	Through study completion, around 1 year and a half