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

NCT ID: NCT06918652

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-20
• Study Completion Date: 2025-12-31

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.

Conditions

High-risk Patients With Acute Calculous Cholecystitis (ACC)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Transmural ultrasound-guided gallbladder drainage

Patients randomized to TUGD arm will receive endoscopic transmural ultrasound-guided gallbladder drainage with lumen-apposing self-expandable metal stents (LAMSs)

Group Type: EXPERIMENTAL

Transmural ultrasound-guided gallbladder drainage

Intervention Type: PROCEDURE

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

Patients randomized to control arm (LC) will receive laparoscopic cholecystectomy.

Group Type: ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia

OTHER

Sponsor Role: lead

Responsible Party

Luca Ansaloni

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luca Ansaloni, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Policlinico San Matteo di Pavia

Locations

SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Luca Ansaloni, MD

Role: CONTACT

l.andaloni@smatteo.pv.it

+390382502530

Other Identifiers

SETIMIHRACC

Identifier Type: -

Identifier Source: org_study_id