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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05525442
• Other study ID #: 2021/05-12
• Status: Completed
• Start date: January 1, 2015
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2022
• Source: Tepecik Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Acute cholecystitis is an inflammatory disease of the gallbladder and is often associated with cholelithiasis. According to Tokyo Guide 2018 (TG18), acute cholecystitis is grouped with various risk factors and predictive factors. Early laparoscopic cholecystectomy or late cholecystectomy after medical therapy is recommended for patients with grades 1 and 2. On the other hand, non-operative treatments such as percutaneous cholecystostomy catheter and antibiotic therapy are recommended for selected patients with high surgical risk and serious comorbidities in order to prevent morbidity and mortality. They suggested that percutaneous cholecystostomy catheter could be used as the definitive treatment of acute cholecystitis in these high-risk patients who are not suitable for surgery. Debate continues as to whether cholecystectomy is necessary for these patients. Because studies have shown that the recurrence rate of acute cholecystitis after percutaneous cholecystostomy catheter treatment varies between 4% and 22%. For these reasons, assessing the risk of recurrence of acute cholecystitis in patients initially treated with percutaneous cholecystostomy is essential to aid decision making.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Recurrence

Intervention

Procedure:
• percutaneous cholecystostomy
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tepecik Training and Research Hospital

References & 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, Giménez ME, Huang WS, Kim MH, Okamoto K, Belli G, Dervenis C, Chan ACW, Lau WY, — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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