EGDB: EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04197908

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis	Device: EUS-guided gallbladder drainage (EGBD)	N/A

Detailed Description

The gold standard for treatment of acute calculous cholecystitis is laparoscopic cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD) has been described as a treatment option. However, whether this is an effective treatment option in surgically fit patients are uncertain.

The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy. The investigators hypothesis that the technique is safe and feasible.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study

Actual Study Start Date :

Nov 29, 2019

Anticipated Primary Completion Date :

Jun 30, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EUS-guided gallbladder drainage (EGBD) The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean.	Device: EUS-guided gallbladder drainage (EGBD) As listed in the arms description

Arm

Intervention/Treatment

Experimental: EUS-guided gallbladder drainage (EGBD)

The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean.

Device: EUS-guided gallbladder drainage (EGBD)

As listed in the arms description

Outcome Measures

Primary Outcome Measures

Clinical success rate [30 days]
Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%

Secondary Outcome Measures

Technical success rate [30 days]
Defined as successful placement of a metal stent between the gallbladder and the duodenum or the stomach
30-day adverse events rate [30 days]
Adverse events would be graded according to the lexicon of endoscopic adverse events
Stone or polyp recurrences [3 years]
An ultrasonography of the abdomen would also be arranged yearly to check for recurrence of stones or polyps.
Quality of life scores: Gastrointestinal quality of life index [3 years]
Gastrointestinal quality of life index
Mortality rate [3 years]
Death from any cause
Reintervention rate [3 years]
The number of patients requiring biliary related re-interventions within 3 years.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous cholecystitis indicated for laparoscopic cholecystectomy would be included.

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)
Patients with duodenal obstruction
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: international normalised ratio (INR) > 1.5 and/or platelets < 50.000/mm3
Previous drainage of the gallbladder