NCT05153031

Brief Summary

Percutaneous cholecystostomy (PC) is an increasingly performed procedure for acute cholecystitis (AC), safe and less invasive than laparoscopic cholecystectomy, very useful in selected patients (severe comorbidities, not suitable for surgery/general anesthesia,..) The investigators conduct a retrospective observational study. Period: 2016-2021. Inclusion criteria: Patients treated with PC for AC. Tokyo guidelines TG13/18 the investigators algorithm to treat AC. The characteristics of the sample undergoing Percutaneous Cholecystostomy, main indications, evolution and clinical results were reported in an initial observational study. Subsequently, a retrospective analytical study was designed to compare various cohorts: lithiasic vs alithiasic Acute Cholecystitis, elective vs emergency surgery or management with PC alone.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 10, 2021

Completed
Last Updated

December 10, 2021

Status Verified

December 1, 2021

Enrollment Period

5.2 years

First QC Date

November 7, 2021

Last Update Submit

December 9, 2021

Conditions

Acute CholecystitisPercutaneous Cholecystostomy

Keywords

Acute Cholecystitispercutaneous cholecystostomylaparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (3)

  • global successful rate

    the patient did not require a new drain or emergency surgery, did not die due to the infection, and could be discharged from hospital after PC removal

    through study completion, an average of 1.5 year

  • 90-days mortality

    90 days

  • complications rate

    through study completion, an average of 1.5 year

Secondary Outcomes (5)

  • total length of hospitalization during acute episode

    through study completion, an average of 1.5 year

  • drainage duration

    through study completion, an average of 1.5 year

  • 1-year readmission rate due to biliary complications

    1 year

  • The degree of adherence to treatment algorithm of the Tokyo Guidelines 13/18 in the indication of PC

    through study completion, an average of 1.5 year

  • cholecystectomy rate

    through study completion, an average of 1.5 year

Study Arms (6)

lithiasic acute cholecystitis

Acute cholecystitis with the presence of one or more calculi (gallstones) in the gallbladder.

Other: lithiasic

alithiasic acute cholecystitis

Acute cholecystitis without the presence of one or more calculi (gallstones) in the gallbladder.

elective cholecystectomy

Elective surgery is surgery that is scheduled in advance because it does not involve a medical emergency.

emergency cholecystectomy

Emergence surgery

Procedure: Emergency surgery

management with percutaneous cholecystostomy alone

Patients that didnt recieve cholecystectomy during de whole study

managemente with surgery

Patients that recieve cholecystectomy during de whole study

Procedure: cholecystectomy

Interventions

lithiasicOTHER

Cholelithiasis is the presence of one or more calculi (gallstones) in the gallbladder.

lithiasic acute cholecystitis
Emergency surgeryPROCEDURE

Emergency cholecystectomy

emergency cholecystectomy
cholecystectomyPROCEDURE

cholecystectomy

managemente with surgery

Eligibility Criteria

Age17 Years+
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria

You may qualify if:

  • Patients undergoing PC diagnosed with AC following the TG13 and TG18 diagnostic criteria

You may not qualify if:

  • Patients undergoing PC for causes other than AC, such as neoplasms, bile duct alterations or non-therapeutic diagnostic purposes;
  • Patients who had previously undergone endoscopic drainage.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (10)

  • Miura F, Takada T, Strasberg SM, Solomkin JS, Pitt HA, Gouma DJ, Garden OJ, Buchler MW, Yoshida M, Mayumi T, Okamoto K, Gomi H, Kusachi S, Kiriyama S, Yokoe M, Kimura Y, Higuchi R, Yamashita Y, Windsor JA, Tsuyuguchi T, Gabata T, Itoi T, Hata J, Liau KH; Tokyo Guidelines Revision Comittee. TG13 flowchart for the management of acute cholangitis and cholecystitis. J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):47-54. doi: 10.1007/s00534-012-0563-1.

    PMID: 23307003BACKGROUND

  • 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: 33153472BACKGROUND

  • Gulaya K, Desai SS, Sato K. Percutaneous Cholecystostomy: Evidence-Based Current Clinical Practice. Semin Intervent Radiol. 2016 Dec;33(4):291-296. doi: 10.1055/s-0036-1592326.

    PMID: 27904248BACKGROUND

  • Yokoe M, Takada T, Strasberg SM, Solomkin JS, Mayumi T, Gomi H, Pitt HA, Garden OJ, Kiriyama S, Hata J, Gabata T, Yoshida M, Miura F, Okamoto K, Tsuyuguchi T, Itoi T, Yamashita Y, Dervenis C, Chan AC, Lau WY, Supe AN, Belli G, Hilvano SC, Liau KH, Kim MH, Kim SW, Ker CG; Tokyo Guidelines Revision Committee. TG13 diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2013 Jan;20(1):35-46. doi: 10.1007/s00534-012-0568-9.

    PMID: 23340953BACKGROUND

  • Yokoe M, Hata J, Takada T, Strasberg SM, Asbun HJ, Wakabayashi G, Kozaka K, Endo I, Deziel DJ, Miura F, Okamoto K, Hwang TL, Huang WS, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Noguchi Y, Shikata S, Ukai T, Higuchi R, Gabata T, Mori Y, Iwashita Y, Hibi T, Jagannath P, Jonas E, Liau KH, Dervenis C, Gouma DJ, Cherqui D, Belli G, Garden OJ, Gimenez ME, de Santibanes E, Suzuki K, Umezawa A, Supe AN, Pitt HA, Singh H, Chan ACW, Lau WY, Teoh AYB, Honda G, Sugioka A, Asai K, Gomi H, Itoi T, Kiriyama S, Yoshida M, Mayumi T, Matsumura N, Tokumura H, Kitano S, Hirata K, Inui K, Sumiyama Y, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholecystitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):41-54. doi: 10.1002/jhbp.515. Epub 2018 Jan 9.

    PMID: 29032636BACKGROUND

  • Agha R, Abdall-Razak A, Crossley E, Dowlut N, Iosifidis C, Mathew G; STROCSS Group. STROCSS 2019 Guideline: Strengthening the reporting of cohort studies in surgery. Int J Surg. 2019 Dec;72:156-165. doi: 10.1016/j.ijsu.2019.11.002. Epub 2019 Nov 6.

    PMID: 31704426BACKGROUND

  • Hendrix JM, Garmon EH. American Society of Anesthesiologists Physical Status Classification System. 2025 Feb 11. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK441940/

    PMID: 28722969BACKGROUND

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PMID: 3558716BACKGROUND

  • Clavien PA, Sanabria JR, Strasberg SM. Proposed classification of complications of surgery with examples of utility in cholecystectomy. Surgery. 1992 May;111(5):518-26.

    PMID: 1598671BACKGROUND

  • Rubio-Garcia JJ, Velilla Vico D, Villodre Tudela C, Irurzun Lopez J, Contreras Padilla D, Alcazar Lopez C, Carbonell Morote S, Ramia-Angel JM. Impact of percutaneous cholecystostomy in the management of acute cholecystitis: a retrospective cohort study at a tertiary center. Updates Surg. 2023 Jun;75(4):905-914. doi: 10.1007/s13304-023-01499-3. Epub 2023 Mar 29.

    PMID: 36991301DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Interventions

Cholecystectomy

Condition Hierarchy (Ancestors)

CholecystitisGallbladder DiseasesBiliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 7, 2021

First Posted

December 10, 2021

Study Start

January 1, 2016

Primary Completion

February 28, 2021

Study Completion

November 1, 2021

Last Updated

December 10, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share