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

Acute Cholecystitis Clinical Trial

— EGDB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04197908
• Other study ID #: CREC-2016.609
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2019
• Est. completion date: June 30, 2024

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute

Intervention

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

Locations

Country	Name	City	State
China	Chinese University of Hong Kong	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

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