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Completed

NCT Number: NCT04197908

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese University of Hong Kong

Hong Kong, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EUS-guided gallbladder drainage (EGBD)

Device

As listed in the arms description

Primary outcomes

  1. Clinical success rate

    Time frame: 30 days

    Complete resolution of acute cholecystitis as defined by resolution of fever, pain and change of white cell counts of 10%

Secondary outcomes

  1. Technical success rate

    Time frame: 30 days

    Defined as successful placement of a metal stent between the gallbladder and the duodenum or the stomach

  2. 30-day adverse events rate

    Time frame: 30 days

    Adverse events would be graded according to the lexicon of endoscopic adverse events

  3. Stone or polyp recurrences

    Time frame: 3 years

    An ultrasonography of the abdomen would also be arranged yearly to check for recurrence of stones or polyps.

  4. Quality of life scores: Gastrointestinal quality of life index

    Time frame: 3 years

    Gastrointestinal quality of life index

  5. Mortality rate

    Time frame: 3 years

    Death from any cause

  6. Reintervention rate

    Time frame: 3 years

    The number of patients requiring biliary related re-interventions within 3 years.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: EGDB

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2019
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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