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

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

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

Study Overview

• Status: Completed
• Conditions: Acute Cholecystitis
• Intervention / Treatment: Device: EUS-guided gallbladder drainage (EGBD)

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
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong
    • Hong Kong, Hong Kong, China
      • Chinese University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: EUS-guided gallbladder drainage (EGBD); 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.

Device: EUS-guided gallbladder drainage (EGBD); As listed in the arms description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success rate	Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Defined as successful placement of a metal stent between the gallbladder and the duodenum or the stomach	30 days
30-day adverse events rate	Adverse events would be graded according to the lexicon of endoscopic adverse events	30 days
Stone or polyp recurrences	An ultrasonography of the abdomen would also be arranged yearly to check for recurrence of stones or polyps.	3 years
Quality of life scores: Gastrointestinal quality of life index	Gastrointestinal quality of life index	3 years
Mortality rate	Death from any cause	3 years
Reintervention rate	The number of patients requiring biliary related re-interventions within 3 years.	3 years

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Anthony Teoh, CUHK

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2019
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: December 6, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Laparoscopic cholecystectomy; Acute cholecystitis; EUS-guided gallbladder drainage; gallbladder polyp; gallstone
• Additional Relevant MeSH Terms: Calculi; Pathological Conditions, Anatomical; Digestive System Diseases; Biliary Tract Diseases; Gallbladder Diseases; Cholelithiasis; Cholecystolithiasis; Pathological Conditions, Signs and Symptoms; Cholecystitis; Gallstones; Cholecystitis, Acute
• Other Study ID Numbers: CREC-2016.609

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No