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Clinical Trials in Italy / NCT06918652
Recruiting Not applicable

Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis

NCT06918652 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Phase
Not applicable
Started
2023-10-20
Last updated
2025-04-09

Condition(s) studied

High-risk Patients With Acute Calculous Cholecystitis (ACC)

Investigational drug(s) / intervention(s)

Transmural ultrasound-guided gallbladder drainageLaparoscopic cholecystectomy

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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. — baseline, pre-surgery, day 3
    Difference between the plasma elastase concentration before surgery and on the third postoperative day

Trial sites (1)

FacilityCityRegionStatus
SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo Pavia Pavia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06918652 on ClinicalTrials.gov ↗ ← All trials in Italy