EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.

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Brief Title

EUS-guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis. A Feasibility Study.

Official Title

Endoscopic Ultrasound (EUS)-Guided Gallbladder Drainage Instead of Laparoscopic Cholecystectomy for Acute Cholecystitis: A Feasibility Study

Brief Summary

      To evaluate the feasibility of performing EGBD as a treatment of acute calculous
      cholecystitis in patients that are indicated for laparoscopic cholecystectomy.

Detailed Description

      The gold standard for treatment of acute calculous cholecystitis is laparoscopic
      cholecystectomy. Recently, gallbladder drainage with EUS-guided gallbladder drainage (EGBD)
      has been described as a treatment option. However, whether this is an effective treatment
      option in surgically fit patients are uncertain.

      The aim of the current study is to evaluate the feasibility of performing EGBD as a treatment
      of acute calculous cholecystitis in patients that are indicated for laparoscopic
      cholecystectomy. The investigators hypothesis that the technique is safe and feasible.

Study Type

Interventional

Primary Outcome

Clinical success rate

Secondary Outcome

 Technical success rate

Condition

Acute Cholecystitis

Intervention

EUS-guided gallbladder drainage (EGBD)

Study Arms / Comparison Groups

 EUS-guided gallbladder drainage (EGBD)
Description:  The procedure would be performed with a linear echoendoscope using a 10mm x 10mm or a 15 x 10mm stent. The distal flange of the stent would be deployed under EUS guidance, followed by deployment of the proximal flange under endoscopic guidance. Once deployed, the gallbladder would be completely emptied by suction and irrigation until the effluent through the stent is clean.

Publications

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

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

30

Start Date

November 29, 2019

Completion Date

June 30, 2024

Primary Completion Date

June 30, 2021

Eligibility Criteria

        Inclusion Criteria:

        Consecutive healthy patients aged ≥ 18 years old suffering from acute calculous
        cholecystitis indicated for laparoscopic cholecystectomy would be included.

        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)

          -  Patients with duodenal obstruction

          -  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: international normalised ratio (INR) > 1.5 and/or platelets <
             50.000/mm3

          -  Previous drainage of the gallbladder

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Anthony Teoh, 35052956, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04197908

Organization ID

CREC-2016.609

Responsible Party

Principal Investigator

Study Sponsor

Chinese University of Hong Kong

Study Sponsor

Anthony Teoh, Principal Investigator, CUHK

Verification Date

February 2020