Acute Cholecystitis
Conditions
Keywords
Acute cholecystitis, EUS-guided gallbladder drainage, Laparoscopic cholecystectomy, gallbladder polyp, gallstone
Brief summary
To evaluate the feasibility of performing EGBD as a treatment of acute calculous cholecystitis in patients that are indicated for laparoscopic cholecystectomy.
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.
Interventions
As listed in the arms description
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORAnthony Teoh
CUHK
Outcome results
None listed