None listed
Conditions
Brief summary
The ECHIDNA-01 study is investigating two non-surgical treatments for gallbladder inflammation in patients who are not suitable for surgery. One treatment involves placing a stent inside the body using a camera through the mouth (EUS-GBD), while the other uses a drain tube inserted through the skin (PC). Both procedures are already used in hospitals, but the study aims to find out which one leads to better recovery, improved quality of life, and better overall costs. Patients who need a procedure will be randomly assigned to one of the two options. After treatment, researchers will follow up with each patient by phone over the next year to check on their health and progress. We hypothesise that the EUS-GBD technique will prove superior to PC in recovery, quality of life and overall healthcare cost.
Interventions
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) a procedure performed by a specialist doctor who has completed additional training in the procedure and also in gastrointestinal medicine. It takes approximately 30 minutes to complete. It is performed when the patient is put to sleep using sedation or anaesthesia, then an endoscopic ultrasound camera is placed through the mouth into the stomach and duodenum (1st part of the small intestine) to examine the gallbladder and the surroundin
Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) a procedure performed by a specialist doctor who has completed additional training in the procedure and also in gastrointestinal medicine. It takes approximately 30 minutes to complete. It is performed when the patient is put to sleep using sedation or anaesthesia, then an endoscopic ultrasound camera is placed through the mouth into the stomach and duodenum (1st part of the small intestine) to examine the gallbladder and the surrounding area. Following this, a lumen apposing metal stent is placed, that connects the gallbladder to the stomach or duodenum. This allows the gallbladder to drain and inflammation (and pain) to resolve. If there has been an obstruction leading to jaundice then this should resolve with improvement in blood bilirubin levels. The placement of the stent is confirmed with a low-dose x-ray and also with intra-operative photography. If there is any concern then the placement can be further confirmed with a CT scan but only in very selected cases.
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adult (aged 18 years or over) Diagnosis of confirmed acute cholecystitis according to Tokyo guidelines 2018 Assessed by a consultant general surgeon as not suitable for a laparoscopic or open cholecystectomy Medically suitable/fit for EUS-GBD Able to provide consent
Exclusion criteria
Not able to undergo endoscopy for anaesthetic or other reasons Have previously had surgery precluding endoscopic access Intervening gastric varices precluding access to the gallbladder Not for interventional procedures according to patient/family preference or medical decision (i.e. palliative or ward-based management) Diagnosis of a bleeding diathesis, or anticoagulation medication which is not able to be safely reversed, withheld, or continued Unsuitable for EUS-GBD due to a contracted gallbladder or anatomical reasons (such as the gallbladder not being sufficiently proximate to the duodenum) Perforated gallbladder Previous EUS-GBD Pregnancy at the time of recruitment/procedure Unable to consent
Outcome results
None listed