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

July 3, 2013 updated by: Byung Hyo Cha, MD, Cheju Halla General Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeju special self-governing province
      • Jeju-si, Jeju special self-governing province, Korea, Republic of, 690-766
        • Digestive disease center, Department of Internal Medicine, Cheju Halla General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Transferred patients from other institute after cholecystostomy procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
All cause mortality
Time Frame: within 30 days
within 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 30 days
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
Within 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cheju Halla General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 29, 2013

First Submitted That Met QC Criteria

July 3, 2013

First Posted (ESTIMATE)

July 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

July 10, 2013

Last Update Submitted That Met QC Criteria

July 3, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTGBD1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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