Clinical trial NCT01894321: The Clinical Outcomes of the Percutaneous Cholecystostomy, Supportive Care Versus Cholecystectomy.
Official title: The Percutaneous Cholecystostomy is Appropriate as the Ultimate Treatment of Acute Cholecystitis in Critically Ill Patients: a Cross-sectional Study at Single Center.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Calculous Cholecystitis
Acute Acalculous Cholecystitis
Keywords: Acute cholecystitis
Elderly
Critically ill patients
Surgical high risk
Percutaneous cholecystostomy
Cholecystectomy
Lead sponsor: Cheju Halla General Hospital
Sponsor class: OTHER
First posted: 2013-07-10
Enrollment: 82
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From November 2007 to November 2012, patients admitted with acute cholecystitis through emergency center or out-patient clinic then underwent ultrasonography guided percutaneous cholecystostomy in Cheju Halla General Hospital were enrolled consecutively.

Brief summary: Percutaneous cholecystostomy (PC) is an effective treatment for cholecystitis in surgical high risk patients. However, there has been no definite agreement of the additional cholecystectomy in these patients. The investigators surveyed the clinical outcomes of the PC in surgical high risk patients. And the investigators tried to prove the PC can be appropriate and ultimate treatment for acute cholecystitis patients with critical illness through this study.

Detailed description: Between 2007 and 2012, all patients admitted for acute cholecystitis, and then underwent ultrasonography guided percutaneous cholecystostomy in Cheju Halla General Hospital were consecutively enrolled.

Among 82 patients, 35 were performed laparoscopic cholecystectomy after recovery (Cholecystectomy group) and 47 treated by best supportive care without additional surgery (BSC group).

The investigators analyzed their surgical risks and clinical outcomes of both patients retrospectively.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of acute cholecystitis
* Underwent the ultrasound-guided percutaneous cholecystostomy

Exclusion Criteria:

* Transferred patients from other institute after cholecystostomy procedure.

Primary outcomes:
measure: All cause mortality
timeFrame: within 30 days
Secondary outcomes:
measure: Evidence of recurrent cholecystitis or biliary complication
timeFrame: Within 30 days
measure: Evidence of recurrent cholecystitis or biliary complication
timeFrame: Within 30 days
Other outcomes:
Locations:
city: Jeju-si
country: Korea, Republic of
facility: Digestive disease center, Department of Internal Medicine, Cheju Halla General Hospital
state: Jeju special self-governing province
Study officials:
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