EGDBEUS-Guided Gallbladder Drainage vs Laparoscopic Cholecystectomy for Acute Cholecystitis
This study compares the clinical success rate of two treatments, EUS-Guided Gallbladder Drainage and Laparoscopic Cholecystectomy, in resolving acute cholecystitis, measured by the resolution of fever, pain, and a change in white cell counts of 10%.
EUS-guided gallbladder drainage (EGBD)
Biliary Tract Diseases+8
+ Calculi
+ Cholecystitis
Treatment Study
Summary
Study start date: November 29, 2019
Actual date on which the first participant was enrolled.Acute calculous cholecystitis, a condition marked by inflammation of the gallbladder due to gallstones, is typically treated through laparoscopic cholecystectomy, a surgical procedure to remove the gallbladder. Recently, a new approach called Endoscopic Ultrasound (EUS)-guided gallbladder drainage (EGBD) has emerged. This study aims to explore the effectiveness of EGBD in patients who are suitable for laparoscopic cholecystectomy. The researchers believe that EGBD could be a safe and practical alternative for these patients, potentially improving care and addressing current challenges in treatment. The study involves evaluating the feasibility of EGBD as a treatment for acute calculous cholecystitis. Participants will undergo EGBD, a procedure that drains the gallbladder using ultrasound guidance. The success of the treatment is measured by the complete resolution of symptoms associated with acute cholecystitis. This includes the disappearance of fever, relief from pain, and a decrease in white cell count by 10%. The study's primary focus is to determine if EGBD can effectively resolve these symptoms in patients who would typically undergo laparoscopic cholecystectomy.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location