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

Phase 2

Completed

• Conditions: Acute Cholecystitis
• Interventions: Procedure: EUS-guided gallbladder drainage (EGBD); Procedure: Percutaneous cholecystostomy (PC)

• Registration Number: NCT02212717
• Lead Sponsor: Chinese University of Hong Kong

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-05
• Study First Submitted QC: 2014-08-06
• Study First Posted: 2014-08-08
• Primary Completion: 2018-02
• Study Completion: 2019-03
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EUS-guided gallbladder drainage	EUS-guided gallbladder drainage (EGBD)	-
Percutaneous cholecystomy	Percutaneous cholecystostomy (PC)	-

Primary Outcome Measures

Name	Time	Method
Overall morbidities	1 years

Secondary Outcome Measures

Name	Time	Method
Technical success	30 days	Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent.
Pain scores	7 days	Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7.
Analgesic requirements	7 days	The amount of analgesic consumed during admission will be recorded and compared between groups. Oral panadol and intravenous tramadol (or equivalent) would be provided as required to patients.
Stone clearance rates	1 years	The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography
Clinical success	30 days	Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts.
Reintervention rate	1 year	The number of patients requiring biliary related re-interventions within 1 year
Re-admission rate	1 year	The number of patients requiring hospital re-admissions due to biliary related events

Trial Locations

Locations (4)

Chinese University of Hong Kong; 🇨🇳 Hong Kong, Hong Kong, China

Kinki University Hospital; 🇯🇵 Osaka, Japan

University Hospital Rio Hortega; 🇪🇸 Barcelona, Spain

Tokyo Medical University Hospital; 🇯🇵 Tokyo, Japan