An observational study in Cholecystitis, Acute, sponsored by Catholic University of the Sacred Heart. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-14.
Sponsored by Catholic University of the Sacred Heart · Observational
This study evaluates the long-term safety and efficacy of the Hong Kong follow up protocol in patients who will undergo drainage of the gallbladder under endoultrasonography (EUS) guidance in patients with acute cholecistitis not suitable for surgery.
Acute cholecystitis is a common surgical condition. However, in elderly patients or patients with significant comorbidity, emergency laparoscopic cholecystectomy can be associated with significant risk of morbidities. Thus, in these patients, percutaneous cholecystostomy (PC) could be employed for drainage of the gallbladder. However, complications including intrahepatic hemorrhage, pneumothorax, biliary peritonitis and pneumonia have been reported in a mean of 6.2% of patients (range 0-25%). Furthermore, PC has several other disadvantages including risk of bile leakage, recurrent cholecystitis, inadvertent tube removal and migration (0-25%), necessitating repeated procedures. In order to avoid nuisances associated with PC, studies looking at potential ways to achieve endoscopic gallbladder drainage have been performed. On the other hand, EUS-guided transmural drainage procedures are increasingly performed for management of a variety of conditions and has also been described for drainage of the gallbladder in patients that are not fit for surgery since 2007. Recently, a lumen-apposing metal stent (LAMS) has become available which allows easier deployement of the stent. A 9.8mm gastroscope or a 5mm ultrathin nasal endoscope can pass through the lumen of the stent and enter the gallbladder for stone removal or other interventions A recent study group from Hong Kong promoted a specific follow up for EUS guided gallbaldder drainage patients who underwent a follow-up cholecystoscopy after the procedure to check for clearance of stones. In patients with stones that were too large to pass out spontaneously, basket mechanical lithotripsy was employed to break down the stones, followed by laser lithotripsy if the latter was not successful. No data on the safety and efficacy of the Hong Kong follow up protocol in patients who underwent EGBD using LAMS coming from countries other than Asian are available, in which differences in etiological and pathogenic factors might not required such an intensive follow up protocol. To explore this important question we have designed a study aimed at evaluating the long-term safety and efficacy of the Hong Kong follow up protocol in patients undergoing EGBD performed using LAMS.
266 studies on the registry are indexed under Cholecystitis; 46 are open to participants now.
This study's enrollment of 24 is below the median of 200 across 90 observational studies indexed under Cholecystitis.
Browse Cholecystitis studies →Catholic University of the Sacred Heart is the lead sponsor of 227 studies on the registry; 28 are open to participants now.
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This study concerns consecutive patients undergoing EGBD using LAMS as per decision of the on call surgeons of the Emergency Surgery Department with diagnosis of acute cholecystitis, who are unsuitable for early laparoscopic cholecystectomy due to poor premorbid conditions
Exclusion Criteria:
EUS-GBD will be performed using LAMS (such as Hot-AxiosTM device). A 10mm x 10mm stent system will be used if the largest gallstone is smaller than 10mm in size and a 15 x 10mm stent will be used if the largest gallstone is larger than 10mm. Colecystoscopy will be subsequently performed after at least 2 weeks using standard or therapeutic gastroscope. Lithotripsy will be performed using mechanical lithotripsy or laser lithotripsy.
Incidence of adverse events after EUS gallbladder drainage and cholecystoscopy
Percentage adverse events after the procedures. Adverse events will be considered major if they prevent completion of the scheduled procedure and/or resulted in prolongation of hospital stay, another therapeutic procedure (needing sedation/anesthesia), or subsequent medical consultation. Any potential adverse event such as pancreatitis, burns of the gastric or duodenal walls, bowel injury, or peritonitis will be recorded and graded according to the above-mentioned classification.
Time frame: From date of treatment every 2-3 months, assessed until death or up to 2 years
Incidence of recurrent acute cholecystitis after EUS-GBD and cholecystoscopy
Percentage of patients with recurrent acute cholecystitis symptoms after EUS-GBD and cholecystoscopy with residual stone removal if present after resolution of the index episode.
Time frame: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Incidence of patients with resolution of acute cholecystitis symptoms after EUS-GBD
Percetange of patients achieving acute cholecystitis symptoms resolution after EUS-GBD demonstrated by normalization of clinical parameters of acute cholecystitis within 96 hours. Clinical parameters reported are abdominal pain evaluated by the patients on a 10-point visual analogue scale, temperature, white blood cell count and serum C-reactive protein concentration.
Time frame: Within 96 hours after procedure
Need for advaced gallbladder interventions
Number of patients who will require more advanced gallbladder interventions during follow up such as colecystoscopy lithotripsy will be assessed by the numebr of patients who will require such treatments.
Time frame: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Need for ERCP
rate of patients who will require ERCP due to stones migration during colecystoscopy will be assessed by the number of patients who will require such intervention.
Time frame: From date of treatment, every 2-3 months, assessed until death or up to 2 years
Plan to share: No
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Catholic University of the Sacred Heart