Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis

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Brief Title

Hong Kong Follow up Protocol After EUS Gallbladder Drainage for Acute Cholecistitis

Official Title

Endoscopic Ultrasound-guided Gallbladder Drainage in High Surgical Risk Patients With Acute Cholecystitis: Prospective Evaluation of the Hong Kong Follow up Protocol

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

Incidence of adverse events after EUS gallbladder drainage and cholecystoscopy

Secondary Outcome

 Incidence of patients with resolution of acute cholecystitis symptoms after EUS-GBD

Condition

Cholecystitis, Acute


Study Arms / Comparison Groups

 EUS guided gallbladder drainage and cholecystoscopy
Description:  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.

Publications

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

Recruitment Information



Estimated Enrollment

30

Start Date

May 6, 2020

Completion Date

December 2023

Primary Completion Date

December 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Consecutive patients with acute cholechystitis unsuitable for surgery

          -  age ≥ 18 years old

          -  Written informed consent from patient or guardian who is able to understand the nature
             and possible consequences of the study

        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)

          -  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 (INR > 1.5 and/or platelets < 50.000/mm3)

          -  Contraindication to perform endoscopy
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Alberto Larghi, MD, Phd, +390630156580, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04874103

Organization ID

EUS-GBD Hong Kong


Responsible Party

Principal Investigator

Study Sponsor

Catholic University of the Sacred Heart


Study Sponsor

Alberto Larghi, MD, Phd, Principal Investigator, Fondazione Policlinico Universitario Agostino Gemelli


Verification Date

May 2021