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

Study Overview
=================
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.

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.

Conditions
-----------------
Acute Cholecystitis

Intervention / Treatment
-----------------
* Procedure: EUS-guided gallbladder drainage (EGBD)
* Procedure: Percutaneous cholecystostomy (PC)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EUS-guided gallbladder drainage<br> | Procedure: EUS-guided gallbladder drainage (EGBD)<br>* The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent.<br>|
| Active Comparator: Percutaneous cholecystomy<br> | Procedure: Percutaneous cholecystostomy (PC)<br>* Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall morbidities |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success is defined as the ability to access and drain the gallbladder by placement of a drainage tube or stent. | 30 days | 
| Pain scores | Pain assessment would be performed using the visual-analogue scale (1 to 100) on post-procedural days 1 to 7. | 7 days | 
| Analgesic requirements | 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. | 7 days | 
| Stone clearance rates | The presence or absence of gallstones after 1 years would be assessed by abdominal ultrasonography | 1 years | 
| Clinical success | Clinical success is obtained when the patient is afebrile and had more than 20% decrease in white cell counts. | 30 days | 
| Reintervention rate | The number of patients requiring biliary related re-interventions within 1 year | 1 year | 
| Re-admission rate | The number of patients requiring hospital re-admissions due to biliary related events | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute cholecystitis, EUS-guided gallbladder drainage, Percutaneous cholecystostomy