The Clinical Outcomes of the Percutaneous Cholecystostomy, Supportive Care Versus Cholecystectomy.

Completed

• Conditions: Acute Calculous Cholecystitis; Acute Acalculous Cholecystitis

• Registration Number: NCT01894321
• Lead Sponsor: Cheju Halla General Hospital

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2013-06-29
• Status Verified: 2013-07
• Study First Submitted QC: 2013-07-03
• Last Update Submitted: 2013-07-03
• Study First Posted: 2013-07-10
• Last Update Posted: 2013-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

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

Exclusion Criteria

• Transferred patients from other institute after cholecystostomy procedure.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	within 30 days

Secondary Outcome Measures

Name	Time	Method
Evidence of recurrent cholecystitis or biliary complication	Within 30 days	Acute cholecystits : fever, abdominal pain, abnormal chemistry results Biliary complication : Gallstone pancreatitis, gallstone ileus or cholangitis

Trial Locations

Locations (1)

Digestive disease center, Department of Internal Medicine, Cheju Halla General Hospital; 🇰🇷 Jeju-si, Jeju special self-governing province, Korea, Republic of