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Completed

NCT Number: NCT05525442

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. recurrence

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Tepecik Training and Research Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Sep 1, 2022
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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