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Endoscopic Ultrasonography (EUS) Guided Gallbladder Drainage With Two Months Stent Removal for Acute Cholecystitis: a Prospective Study

NCT05272007 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2022-04-01

No results posted yet for this study

Summary

Acute cholecystitis (AC) is defined as an acute inflammatory disease of the gallbladder consequently to the presence of sludge or stones. AC accounts for 3-10% of all cases of abdominal pain. Cholecystolithiasis accounts for 90-95% of all causes of acute cholecystitis, while acalculous cholecystitis accounts for the remaining 5-10% of the cases. Laparoscopic cholecystectomy is actually the gold standard treatment for acute cholecystitis (AC) although it is always not suitable for patients who are poor candidates for surgery \[ \]. In 2001 Giovannini et al. described the first EUS-guided biliary drainage (EUS-BD) through a transduodenal access with a needle knife. Subsequently, EUS-BD has considerably evolved thanks to the development of dedicated devices such as lumen apposing metal stents (LAMS), specifically designed for endoscopic ultrasound procedures. LAMS are made up of braided nitinol, that is fully covered with silicone to prevent tissue ingrowth, with wide flanges on both ends to provide anchorage.

Recently, LAMS have been incorporated into a delivery system with an electrocautery mounted on the tip which allows the device to be used directly to penetrate the target structure without the need to utilize a 19G needle, a guidewire, and a cystotome for prior dilation. Different are actually the indication of the LAMS for different disease and its use has been described for drainage of peri-pancreatic fluid collections, common bile duct (CBD), gallbladder, and for creation of gastro-jejuno anastomosis.

Recently, endoscopic gallbladder (GB) drainage was found to be a potentially revolutionary alternative for cholecystectomy for the control of symptoms, definitive treatment, or bridging therapy until surgery is possible.

Before the advent of LAMS, the standard of care of acute cholecystitis (AC) was the percutaneous drainage (PTC) and after the advent of these new stents, different series showed the higher technical and clinical success of the EUS-gallbladder drainage (EUS-GB) for acute cholecystitis, with a lower recurrence rate, than PTC. The superiority of this technique was assessed in terms of technical and clinical success, AEs and AC recurrence if compared to the endoscopic drainage. This could be explained with the use of larger caliber stents, allowing an effective drainage, with low risk of stent occlusion. Finally, a recent study with a long-term follow-up showed as the outcomes of EUS-GBD for AC were comparable with LC with acceptable rates of recurrent acute cholecystitis.

Conditions

  • Acute Cholecystitis

Interventions

PROCEDURE

EUS-biliary drainage

EUS-GBD with LAMS

Sponsors & Collaborators

  • Istituto Clinico Humanitas Mater Domini

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-28
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05272007 on ClinicalTrials.gov