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OpenTrials
Completed

NCT Number: NCT01894321

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive disease center, Department of Internal Medicine, Cheju Halla General Hospital

Jeju City, Jeju Special Self-governing Province, 690-766, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

  • Transferred patients from other institute after cholecystostomy procedure.

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: within 30 days

Secondary outcomes

  1. Evidence of recurrent cholecystitis or biliary complication

    Time frame: Within 30 days

    Acute cholecysitits : fever, abdominal pain, abnormal chemistry results Biliary complication : Gallstone pancreatitis, gallstone ileus or cholangitis

  2. Evidence of recurrent cholecystitis or biliary complication

    Time frame: Within 30 days

    Acute cholecystits : fever, abdominal pain, abnormal chemistry results Biliary complication : Gallstone pancreatitis, gallstone ileus or cholangitis

Sponsors and collaborators

Lead sponsor

Cheju Halla General Hospital

Other

Registry information

Official study title

The Percutaneous Cholecystostomy is Appropriate as the Ultimate Treatment of Acute Cholecystitis in Critically Ill Patients: a Cross-sectional Study at Single Center.

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Jul 10, 2013
Registry last updated
Jul 10, 2013

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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