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

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

Detailed Description
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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.

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

Conditions
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Acute Cholecystitis

Intervention / Treatment
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* Device: EUS-guided gallbladder drainage (EGBD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EUS-guided gallbladder drainage (EGBD)<br>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)<br>* As listed in the arms description<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical success rate | Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10% | 30 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute cholecystitis, EUS-guided gallbladder drainage, Laparoscopic cholecystectomy, gallbladder polyp, gallstone