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

NCT06314399 | Completed DMC

• 2 other identifiers: 2023-18DVO005 2555-CV1837
• Study Type: observational
• Target: 703
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Biliary Infection; Antibiotic Resistant Strain

Keywords

biliary infection; bactibilia; antibiotic resistance; laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Bile culture positivity

  Bile culture is tested positive for at least one (1) microorganism

  Perioperatively, during the procedure and immediately after the intervention

• 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 Outcomes (5)

• Microbial characteristics

  Immediately after the intervention

• Bile culture and antibiotic resistance relationship

  Immediately after the intervention

• Demographical and clinical characteristics

  Pre-intervention

• Surgical characteristics and outcomes

  During the 15 day postoperative follow-up appointment

• Determination of predictive factors (age, diabetes mellitus, choledocholithiasis / ERCP, C-reactive protein, cholecystitis and Tokyo guidelines severity of cholecystitis)

  Through study completion, around 1 year and a half

Interventions

Bile culture and phenotypic antibiogram resistance test DIAGNOSTIC_TEST

Extraction of 3-5ml of bile from surgical specimen (gallbladder) to be taken for bacterial culture testing and phenotypical antibiogram resistance if positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients that are over 18 years that have an indication for laparoscopic cholecystectomy in our institution without any of the exclusion criteria, which had bile cultures taken from the surgical specimen (gallbladder) during the surgery and attended the postoperative15 day follow-up appointment after hospital discharge.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Hospital Universitario Mayor Méderi: lead
• Universidad del Rosario: collaborator

Study Sites (2)

Hospital Universitario Mayor-Méderi

Bogota, Cundinamarca, 111221, Colombia

Location

Hospital Universitario Méderi Barrios Unidos

Bogota, Cundinamarca, 111221, Colombia

Location

Related Publications (13)

• 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.

  PMID: 31586461 BACKGROUND

• 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.

  PMID: 33153472 BACKGROUND

• 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.

  PMID: 18369670 BACKGROUND

• 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.

  PMID: 34088947 BACKGROUND

• 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.

  PMID: 26328034 BACKGROUND

• 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.

  PMID: 29090866 BACKGROUND

• 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.

  PMID: 33412630 BACKGROUND

• 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.

  PMID: 33610257 BACKGROUND

• 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.

  PMID: 36804057 BACKGROUND

• 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.

  PMID: 33860354 BACKGROUND

• 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.

  PMID: 34540214 BACKGROUND

• 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.

  PMID: 31359494 BACKGROUND

• Ramirez-Giraldo C, Rodriguez Barbosa C, Isaza-Restrepo A, Avendano-Morales V, Rojas-Lopez S, Van-Londono I. Predictive factors associated with Bile culture positivity And phenotypiCal antIbiogram resistance patterns in patients taken to LaparOscopic cholecystectomy (BACILO): protocol for a prospective observational cohort study and development of a prognostic prediction model. BMJ Open. 2024 Nov 1;14(10):e086655. doi: 10.1136/bmjopen-2024-086655.

  PMID: 39486833 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

3-5cm of bile will be extracted from the surgical specimen (gallbladder), during laparoscopic cholecystectomy to be taken for bacterial cultures and phenotypical antibiogram resistance pattern if it is positive.

MeSH Terms

Conditions

Cholangitis

Condition Hierarchy (Ancestors)

Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator - General Surgeon

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 18, 2024
• Study Start: April 1, 2024
• Primary Completion: October 26, 2024
• Study Completion: December 24, 2024
• Last Updated: March 18, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: It is in our plans once we obtain a register number from Clinical Trials in order to publish the protocol, statistical analysis plan and clinical study report in a scientific journal so it will be available to all people interested.
• Access Criteria: It is in our plans to be published in a scientific journal available to all people interested.

Locations

CO (2)