Acute Calculous Cholecystitis
Conditions
Keywords
Acute Calculous Cholecystitis, Endoscopic Ultrasound-Guided Gallbladder Drainage, Endoscopic Gallbladder Stenting, Poor Surgical Candidates
Brief summary
This multicenter, prospective, open-label, randomized controlled trial compares endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) with endoscopic transpapillary gallbladder drainage (EGBS) in poor surgical candidates with acute calculous cholecystitis. Eligible patients will be randomized in a 1:1 ratio to undergo either EUS-GBD using a lumen-apposing metal stent or EGBS using a transpapillary plastic stent. The primary endpoint is clinical success, defined as successful gallbladder drainage with subsequent improvement of acute cholecystitis without the need for additional gallbladder drainage. Secondary endpoints include technical success, adverse events, reintervention rate, procedure time, length of hospital stay, and 30-day mortality. The trial aims to determine whether EUS-GBD provides superior clinical outcomes compared with EGBS in this high-risk population.
Detailed description
Acute calculous cholecystitis is a common condition for which early laparoscopic cholecystectomy is the standard treatment. However, some patients are poor surgical candidates because of advanced age, severe comorbidities, poor performance status, or refusal of surgery. In such cases, gallbladder drainage is required. Endoscopic gallbladder drainage has become an alternative to percutaneous drainage because it avoids external drainage tubes and may improve patient comfort and quality of life. Endoscopic transpapillary gallbladder drainage (EGBS) is an established endoscopic approach, but it is technically challenging because selective cannulation of the cystic duct is often difficult. Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) using a lumen-apposing metal stent (LAMS) has recently emerged as a promising alternative with high technical and clinical success rates. However, prospective randomized evidence directly comparing EUS-GBD with EGBS is lacking. This study is a multicenter, prospective, parallel-group, open-label randomized controlled trial designed to compare EUS-GBD and EGBS in poor surgical candidates with acute calculous cholecystitis. After written informed consent and confirmation of eligibility, participants will be randomized in a 1:1 ratio to either the EUS-GBD group or the EGBS group using a web-based central registration system. In the EUS-GBD group, gallbladder drainage will be performed under endoscopic ultrasound guidance using a commercially available LAMS. In the EGBS group, gallbladder drainage will be performed by a transpapillary approach with placement of a plastic stent. Procedures will be performed as early as possible after enrollment, preferably within 24 hours. The primary endpoint is clinical success, defined as successful gallbladder drainage followed by improvement of acute cholecystitis without the need for additional gallbladder drainage. Secondary endpoints include technical success, procedure-related adverse events, reintervention rate, procedure time, length of hospital stay, and 30-day mortality. Long-term follow-up data, including recurrent cholecystitis, late adverse events, reinterventions, and survival, will also be collected. The study aims to establish high-level evidence regarding the optimal endoscopic gallbladder drainage strategy for poor surgical candidates with acute calculous cholecystitis.
Interventions
Endoscopic ultrasound-guided gallbladder drainage performed using a commercially available lumen-apposing metal stent (AXIOS™, Boston Scientific). The procedure is performed under endoscopic ultrasound guidance through the stomach or duodenum to achieve internal gallbladder drainage.
Endoscopic transpapillary gallbladder drainage performed by ERCP with placement of a 7 Fr plastic stent into the gallbladder through the cystic duct.
Sponsors
Aichi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with acute calculous cholecystitis according to the Tokyo Guidelines 2018 diagnostic criteria. * Poor surgical candidate for cholecystectomy, determined comprehensively based on clinical condition, including advanced age, comorbidities, performance status, anesthetic risk, or patient refusal of surgery. * Requires gallbladder drainage for treatment of acute cholecystitis. * Age 18 years or older at the time of consent. * Provides written informed consent before study enrollment.
Exclusion criteria
* No gallstones identified. * Suspected gallbladder carcinoma. * Gallbladder perforation. * No gallbladder distension. * Surgically altered anatomy. * Concomitant common bile duct stones. * Bile duct stricture. * Massive ascites. * Gastric or duodenal stenosis. * Considered unsafe for endoscopic intervention. * Pregnant or possibly pregnant. * Judged unsuitable for the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success Rate | Within 14 days after the index gallbladder drainage procedure | Clinical success is defined as successful gallbladder drainage followed by improvement of acute cholecystitis without the need for additional gallbladder drainage. Improvement includes resolution of fever, abdominal pain, and inflammatory findings such as leukocytosis. The primary analysis will be performed in the intention-to-treat population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success Rate | At the index procedure | Technical success is defined as successful completion of the assigned gallbladder drainage procedure with appropriate stent placement in the gallbladder. |
| Adverse Event Rate | Within 14 days after the index procedure, with additional follow-up assessed up to 3 year | Adverse events related to the gallbladder drainage procedure will be recorded, including bile leak, bleeding, stent migration, stent occlusion, pancreatitis, cholangitis, liver abscess, gastrointestinal perforation, biliary peritonitis, and aspiration pneumonia. |
| Reintervention Rate | Within 30 days after the index procedure, with additional follow-up assessed up to 3 year | Reintervention is defined as any additional procedure required after the initial gallbladder drainage for recurrent cholecystitis, insufficient drainage, stent-related complications, or other biliary events including cholangitis or common bile duct stones. |
| Procedure Time | At the index procedure | Procedure time is defined as the time in minutes from endoscope insertion to endoscope removal during the initial gallbladder drainage procedure. |
| Length of Hospital Stay | From the index procedure to hospital discharge, up to 30 days | Length of hospital stay is defined as the number of days from the initial study intervention to hospital discharge. |
| 30-Day Mortality | Within 30 days after the index procedure | All-cause mortality within 30 days after gallbladder drainage will be assessed. Cause of death, including whether it was related to cholecystitis or the procedure, will be recorded when available. |
Countries
Japan
Contacts
CONTACTTadahisa Inoue
STUDY_CHAIRTadahisa Inoue
Department of Gastroenterology, Aichi Medical University
Outcome results
None listed