Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transmural ultrasound-guided gallbladder drainage, Laparoscopic cholecystectomy.
- Who it may be relevant to
- Registry conditions: High-risk Patients With Acute Calculous Cholecystitis (ACC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Randomized controlled trial on high-risk patients with ACC. Consecutive patients with a diagnosis of ACC, if they meet the inclusion and exclusion criteria, will be randomized to receive Laparoscopic cholecystectomy (LC) or transmural ultrasound-guided gallbladder drainage (TUGD) with lumen-apposing self-expandable metal stents (LAMSs) within 10 days from onset of symptoms. Blood cultures will be performed at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. Bile samples will be taken during the procedure for microbiological exam and culture. Blood samples will collected from all patients at the time of admission, just before the procedure, 24 ± 3h after procedure, 72 ± 3h after procedure. The follow-up will be performed after 30 days and after 6 months from intervention with an outpatient medical examination.
Interventions
- Procedure Transmural ultrasound-guided gallbladder drainage
TUGD will be performed using the bi-flanged LAMSs mounted on an electrocautery-enhanced delivery system (Hot-AXIOS™) by an experienced endoscopist defined as \> 10 LAMS positioning per year. The diameter and length of the stent and the modality of placing the stent (under complete EUS view or with endoscopic or fluoroscopic guidance) will be chosen at the discretion of the endoscopist performing the procedure - Procedure Laparoscopic cholecystectomy
LC will be performed by the four-trocar technique with transection of the cystic duct and cystic artery after reaching the critical view of safety. ELC will be performed by a surgeon trained and experienced in laparoscopic surgery defined as \> 5 laparoscopic procedures for ACC on a yearly basis
Primary outcome measures
- The primary objective of the study is to find if TUGD with LAMSs, compared to LC, has a lower inflammatory and immunologic impact on high-risk patients with ACC. [Time frame: baseline, pre-surgery, day 3]
Secondary outcome measures (12)
- difference between the plasma concentration biochemical and immunological parameters [Time frame: baseline, pre-surgery, day 1, day 3]
- 30-day postoperative complication rate according to Clavien-Dindo [Time frame: day 30]
- 30-day postoperative biliary complication rate [Time frame: day 30]
- 30-day postoperative mortality rate [Time frame: day 30]
- Intraoperative complication rate [Time frame: day 0]
- Failure rate of performing the procedure [Time frame: day 0]
- Operative times [Time frame: through study completion, an average of 2 years]
- Postoperative length of stay (PO-LOS) [Time frame: through study completion, an average of 2 years]
- Total length of stay (T-LOS) [Time frame: through study completion, an average of 2 years]
- Total readmission rate within 6 months [Time frame: 6 Months after procedure]
- Readmission rate within 6 months due to Gallstones Relates Events (GRE) [Time frame: 6 Months after procedure]
- Outcomes of blood and bile cultures (to define the infectious state of the patient) [Time frame: Baseline, pre-surgery, during the surgery, day 1, day 3]
Eligibility criteria
Inclusion criteria
- have a diagnosis of ACC as defined by 2018 Tokyo Guidelines criteria
- be ≥ 18 years old
- have a POSSUM PS ≥ 25
- onset of symptoms <= 7 days before Emergency Department (ED) admission
- provide signed and dated informed consent form
- willing to comply with all study procedures and be available for the duration of the study
- have an Israelian Score (IS) (Table 3) for the risk of main bile duct stones <2 or an IS =2 and an EUS or a MRCP negative for main bile duct stones
Exclusion criteria
- Pregnancy
- Patients unwilling to undergo follow-up assessments
- Patients diagnosed with concomitant pancreatitis
- Acute cholecystitis not related to a gallstone etiology
- Onset of symptoms >7 days before ED admission
- Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum
- Previous drainage of the gallbladder
- Biliary peritonitis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
Italy · 1 center
- SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo — Pavia
Identifiers
NCT: NCT06918652 · SETIMIHRACC