ENDOSCOPIC ULTRASONOGRAPHY (EUS) GUIDED GALLBLADDER DRAINAGE WITH TWO MONTHS STENT REMOVAL FOR ACUTE CHOLECYSTITIS: A PROSPECTIVE STUDY

Brief Title

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

Official Title

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

Brief 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.
    

Study Type

Observational

Primary Outcome

Technical success of EUS-GBD

Condition

Acute Cholecystitis

Intervention

EUS-biliary drainage

Study Arms / Comparison Groups

 Acute cholecystitis

Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

30

Start Date

February 28, 2022

Completion Date

December 31, 2024

Primary Completion Date

December 31, 2024

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 years

          -  Patients arrived to the ER for AC with clinical and radiological evidence of AC (such
             as abdominal ultrasound, computed tomography or magnetic resonance)

          -  EUS gallbladder accessibility from the duodenum or from the stomach for the drainage

          -  Agree to receive follow up phone calls

          -  Able to provide written informed consent

        Exclusion Criteria:

          -  Coagulation and/or platelets hereditary disorders and/or INR>1.5, PLT<50,000

          -  Use of anticoagulants that cannot be discontinued

          -  Pregnant women

          -  Inability to sign the informed consent
      

Gender

All

Ages

18 Years - N/A

Contacts

, (+39) 0331 476205 - 381, [email protected]

Location Countries

Italy

Location Countries

Italy

NCT ID

NCT05272007

Organization ID

06-2022

Responsible Party

Sponsor

Study Sponsor

Istituto Clinico Humanitas Mater Domini

Study Sponsor

, , 

Verification Date

March 2022