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Biliary InfectionBACILONCT06314399

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

An observational study of Biliary Infection and Antibiotic Resistant Strain, run by Hospital Universitario Mayor Méderi at 2 sites in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Bile culture and phenotypic antibiogram resistance test
How many people
703 participants
Where
2 sitesColombia
Study dates
1 Apr 2024to 24 Dec 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • - 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.

Trial locations and contacts

2 sites in 1 country.

Colombia2 sites

  • Hospital Universitario Mayor-Méderi

    Bogota, Cundinamarca, 111221

  • Hospital Universitario Méderi Barrios Unidos

    Bogota, Cundinamarca, 111221

Other trials in Colombia

About this study

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

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.

Read the detailed 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.

Being tested
Bile culture and phenotypic antibiogram resistance test
Keywords
biliary infection, bactibilia, antibiotic resistance, laparoscopic cholecystectomy
Medical subject headings
Cholangitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bile culture and phenotypic antibiogram resistance testDiagnostic test

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bile culture positivity

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

    Measured: Perioperatively, during the procedure and immediately after the intervention

  2. Phenotypical antibiogram resistance

    If bile culture is positive, evaluation for possible antibiotic resistance vs sensitivity

    Measured: Perioperatively, during the procedure and immediately after the intervention

Secondary outcomes (5)

  1. Microbial characteristics

    To describe the microbial characteristics of the bile cultures and their phenotypical antibiogram resistance

    Measured: Immediately after the intervention

  2. Bile culture and antibiotic resistance relationship

    Explore the relationship between positive bile cultures and phenotypical antibiogram resistance with surgical outcomes

    Measured: Immediately after the intervention

  3. Demographical and clinical characteristics

    To describe and compare the demographic and clinical characteristics of the study population.

    Measured: Pre-intervention

  4. Surgical characteristics and outcomes

    To describe and compare the surgical characteristics and outcomes of the study population

    Measured: During the 15 day postoperative follow-up appointment

  5. 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.

    Measured: Through study completion, around 1 year and a half

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion26 Oct 2024
  4. Study completion24 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
703 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06314399
Sponsor's protocol ID
2023-18
Other IDs
DVO005 2555-CV1837
Acronym
BACILO
Status last verified
Mar 2024
First submitted
8 Mar 2024
Last updated
18 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained and input into the database is anonymous, without any individual or identifying characteristics will be stored in a dataset from the Centro de Recursos para el Aprendizaje y la Investigación, property of and administered by the Universidad del Rosario as a plan of data management. Moreover, the different codes used in the analysis will be stored in this dataset.

Publications

  • 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.

    PubMed 31586461

  • 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.

    PubMed 33153472

  • 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.

    PubMed 18369670

  • 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.

    PubMed 34088947

  • 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.

    PubMed 26328034

  • 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.

    PubMed 29090866

  • 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.

    PubMed 33412630

  • 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.

    PubMed 33610257

  • 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.

    PubMed 36804057

  • 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.

    PubMed 33860354

  • 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.

    PubMed 34540214

  • 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.

    PubMed 31359494

  • Van-Londono I, Ramirez-Giraldo C, Moreno-Martinez S, Rodriguez-Barbosa C, Robayo-Romero MG, Maldonado E, Rojas Lopez S, Isaza-Restrepo A. Bile Microbiology and Risk Factors Associated with Antibiotic Resistance Patterns in Patients Taken to Laparoscopic Cholecystectomy: A Prospective Cohort Study. Antibiotics (Basel). 2026 Jul 24;15(8):717. doi: 10.3390/antibiotics15080717.

    PubMed 42650642

  • 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.

    PubMed 39486833

Questions about this trial

What is this clinical trial studying?

An observational study of Biliary Infection and Antibiotic Resistant Strain, run by Hospital Universitario Mayor Méderi at 2 sites in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bile culture positivity (time frame: Perioperatively, during the procedure and immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06314399, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.

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