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

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Brief Title

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

Official Title

Endosonography-guided Gallbladder Drainage (EGBD) Versus Percutaneous Cholecystostomy (PC) in Patients Suffering From Acute Cholecystitis That Are Unsuitable for Surgery. A Randomized Controlled Trial.

Brief 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.

Study Phase

Phase 2/Phase 3

Study Type

Interventional

Primary Outcome

Overall morbidities

Secondary Outcome

 Technical success

Condition

Acute Cholecystitis

Intervention

EUS-guided gallbladder drainage (EGBD)

Study Arms / Comparison Groups

 EUS-guided gallbladder drainage
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

60

Start Date

August 2014

Completion Date

March 2019

Primary Completion Date

February 2018

Eligibility Criteria

        Inclusion Criteria:

          -  Consecutive patients aged ≥ 18 years old admitted for acute cholecystitis but are
             unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions
             including: American society of anesthesiology grading ≥ 3, APACHE score ≥ 12, limited
             life expectancy (less than 2 years) or deemed unsuitable for general anesthesia would
             be included.

          -  Written informed consent from patient or guardian who is able to understand the nature
             and possible consequences of the study

        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 elevated
             serum 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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT02212717

Organization ID

CREC-2014.301-T

Responsible Party

Principal Investigator

Study Sponsor

Chinese University of Hong Kong

Collaborators

 American Society for Gastrointestinal Endoscopy

Study Sponsor

, ,

Verification Date

July 2019