A Randomized Controlled Trial on EGBD vs PC for Acute Cholecystitis.

Last updated: July 29, 2019
Sponsor: Chinese University of Hong Kong
Overall Status: Completed

Phase

2/3

Condition

Liver Disorders

Intra-abdominal Infections

Liver Disease

Treatment

N/A

Clinical Study ID

NCT02212717
CREC-2014.301-T
  • Ages > 18
  • All Genders

Study Summary

Acute cholecystitis commonly occurs in elderly patients that are high-risk candidates for surgery. Percutaneous cholecystostomy (PC) is frequently employed for gallbladder drainage in these patients. Recently, the feasibility of EUS-guided gallbladder drainage (EGBD) in treatment of this condition has been demonstrated but how the two procedures compare to one another is uncertain.

The aim of this study is to compare EGBD versus PC as a definitive treatment, in high-risk patients suffering from acute cholecystitis in a randomized controlled trial. We hypothesize that EGBD can reduce the morbidity, re-intervention and mortality when compared to PC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but areunsuitable for early laparoscopic cholecystectomy due to poor premorbid conditionsincluding: American society of anesthesiology grading ≥ 3, APACHE score ≥ 12, limitedlife expectancy (less than 2 years) or deemed unsuitable for general anesthesia wouldbe included.

  • Written informed consent from patient or guardian who is able to understand the natureand possible consequences of the study

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Patients unwilling to undergo follow-up assessments

  • Patients with suspected gangrene or perforation of the gallbladder

  • Patients diagnosed with concomitant liver abscess or pancreatitis (defined as elevatedserum amylase more than three times the upper limit of normal)

  • Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus,stomach and duodenum

  • Patients with liver cirrhosis, portal hypertension and/or gastric varices

  • Abnormal coagulation: INR > 1.5 and/or platelets < 50.000/mm3

  • Previous drainage of the gallbladder

Study Design

Total Participants: 60
Study Start date:
August 01, 2014
Estimated Completion Date:
March 31, 2019

Connect with a study center

  • Chinese University of Hong Kong

    Hong Kong, Hong Kong
    China

    Site Not Available

  • Kinki University Hospital

    Osaka,
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Tokyo,
    Japan

    Site Not Available

  • University Hospital Rio Hortega

    Barcelona,
    Spain

    Site Not Available

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