Factors Affecting The Recurrence Of Acute Cholecystitis After Treatment With Percutaneous Cholecystostomy

NCT05525442 | Completed

• 1 other identifier: 2021/05-12
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

Brief Summary

Percutaneous cholecystostomy is used to reduce the complications and mortality associated with surgery in patients with high surgical risk in acute cholecystitis. Although this method generally acts as a bridge treatment for interval cholecystectomy in patients, interval cholecystectomy is not performed in every patient after percutaneous cholecystostomy. The aim of this study was to determine the recurrence rate of patients who did not have interval cholecystectomy after treatment with percutaneous cholecystostomy and to investigate the factors that may affect the recurrence.

Conditions

Acute Cholecystitis; Percutaneous Cholecystostomy; Recurrence

Keywords

acute cholecystitis; percutaneous cholecystostomy; Tokyo guidelines 2018; recurrence

Outcome Measures

Primary Outcomes (1)

• recurrence

  Factors affecting recurrence will be investigated in patients who underwent percutaneous cholecystostomy catheter for acute cholecystitis. These factors; age, gender, comorbidities, presence of fever, history of previous cholecystitis attack, catheter insertion time, catheter drainage time, reproduction in bile culture, gallbladder content, various laboratory parameters, gallbladder wall thickness and diameter, Tokyo classification vs.

  one year

Study Arms (2)

patients with recurrence

Recurrence in the first year after percutaneous cholecystostomy catheter removal

Procedure: percutaneous cholecystostomy

patients without recurrence

No recurrence within the first year after percutaneous cholecystostomy catheter removal

Procedure: percutaneous cholecystostomy

Interventions

percutaneous cholecystostomy PROCEDURE

Transhepatic gallbladder drainage was performed under ultrasound guidance after local anesthesia was administered by interventional radiology to patients with acute cholecystitis. Subsequently, an 8-10 Fr pigtail catheter was inserted into the gallbladder using a guide wire under fluoroscopy.

patients with recurrence; patients without recurrence

Eligibility Criteria

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

Study Population

Patients treated with percutaneous cholecystostomy catheter due to acute cholecystitis will be included in the study. Admission to hospital up to 1 year after the acute cholecystitis attack will be retrospectively screened through the hospital data system. The collected data will be statistically analyzed in SPSS.

You may qualify if:

• Diagnosed with acute cholecystitis on admission to the emergency department
• Patients treated with percutaneous cholecystostomy catheter according to TK18 acute cholecystitis diagnosis and treatment guideline
• Patients older than 18 years
• Patients who can give their own consent

You may not qualify if:

• Patients with missing data or not followed up regularly
• Patients whose cholecystostomy catheter was removed during the operation or operated within the first year following the catheter extraction
• Patients with choledocholithiasis, abscess secondary to acute cholecystitis, or hepatopancreatobiliary system malignancy
• Patients who are pregnant

Sponsors & Collaborators

• Tepecik Training and Research Hospital: lead

Related Publications (4)

• Kiriyama S, Kozaka K, Takada T, Strasberg SM, Pitt HA, Gabata T, Hata J, Liau KH, Miura F, Horiguchi A, Liu KH, Su CH, Wada K, Jagannath P, Itoi T, Gouma DJ, Mori Y, Mukai S, Gimenez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, Endo I, Gomi H, Yoshida M, Mayumi T, Baron TH, de Santibanes E, Teoh AYB, Hwang TL, Ker CG, Chen MF, Han HS, Yoon YS, Choi IS, Yoon DS, Higuchi R, Kitano S, Inomata M, Deziel DJ, Jonas E, Hirata K, Sumiyama Y, Inui K, Yamamoto M. Tokyo Guidelines 2018: diagnostic criteria and severity grading of acute cholangitis (with videos). J Hepatobiliary Pancreat Sci. 2018 Jan;25(1):17-30. doi: 10.1002/jhbp.512. Epub 2018 Jan 5.

  PMID: 29032610 RESULT

• Leveau P, Andersson E, Carlgren I, Willner J, Andersson R. Percutaneous cholecystostomy: a bridge to surgery or definite management of acute cholecystitis in high-risk patients? Scand J Gastroenterol. 2008;43(5):593-6. doi: 10.1080/00365520701851673.

  PMID: 18415753 RESULT

• Sanjay P, Mittapalli D, Marioud A, White RD, Ram R, Alijani A. Clinical outcomes of a percutaneous cholecystostomy for acute cholecystitis: a multicentre analysis. HPB (Oxford). 2013 Jul;15(7):511-6. doi: 10.1111/j.1477-2574.2012.00610.x. Epub 2012 Nov 19.

  PMID: 23750493 RESULT

• Li M, Li N, Ji W, Quan Z, Wan X, Wu X, Li J. Percutaneous cholecystostomy is a definitive treatment for acute cholecystitis in elderly high-risk patients. Am Surg. 2013 May;79(5):524-7. doi: 10.1177/000313481307900529.

  PMID: 23635589 RESULT

MeSH Terms

Conditions

Cholecystitis, Acute; Recurrence

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Korhan Tuncer, MD

  Tepecik Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 16, 2022
• First Posted: September 1, 2022
• Study Start: January 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share