Clinical trial NCT06918652: Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
Official title: Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High-risk Patients With Acute Calculous Cholecystitis (ACC)
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: 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.
timeFrame: baseline, pre-surgery, day 3
Secondary outcomes:
measure: difference between the plasma concentration biochemical and immunological parameters
timeFrame: baseline, pre-surgery, day 1, day 3
measure: 30-day postoperative complication rate according to Clavien-Dindo
timeFrame: day 30
measure: 30-day postoperative biliary complication rate
timeFrame: day 30
measure: 30-day postoperative mortality rate
timeFrame: day 30
measure: Intraoperative complication rate
timeFrame: day 0
measure: Failure rate of performing the procedure
timeFrame: day 0
measure: Operative times
timeFrame: through study completion, an average of 2 years
measure: Postoperative length of stay (PO-LOS)
timeFrame: through study completion, an average of 2 years
measure: Total length of stay (T-LOS)
timeFrame: through study completion, an average of 2 years
measure: Total readmission rate within 6 months
timeFrame: 6 Months after procedure
measure: Readmission rate within 6 months due to Gallstones Relates Events (GRE)
timeFrame: 6 Months after procedure
measure: Outcomes of blood and bile cultures (to define the infectious state of the patient)
timeFrame: Baseline, pre-surgery, during the surgery, day 1, day 3
measure: Post-operative pain
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo
Study officials:
affiliation: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Luca Ansaloni, MD
role: PRINCIPAL_INVESTIGATOR
References: