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

NCT06918652 | Recruiting

• 1 other identifier: SETIMIHRACC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (1)

• 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.

  Difference between the plasma elastase concentration before surgery and on the third postoperative day

  baseline, pre-surgery, day 3

Secondary Outcomes (13)

• difference between the plasma concentration biochemical and immunological parameters

  baseline, pre-surgery, day 1, day 3

• 30-day postoperative complication rate according to Clavien-Dindo

  day 30

• 30-day postoperative biliary complication rate

  day 30

• 30-day postoperative mortality rate

  day 30

• Intraoperative complication rate

  day 0

Study Arms (2)

Transmural ultrasound-guided gallbladder drainage

EXPERIMENTAL

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

Procedure: Transmural ultrasound-guided gallbladder drainage

Laparoscopic cholecystectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic cholecystectomy

Interventions

Transmural ultrasound-guided gallbladder drainage 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

Transmural ultrasound-guided gallbladder drainage

Laparoscopic cholecystectomy 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

Laparoscopic cholecystectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo

Pavia, Pavia, 27100, Italy

RECRUITING

MeSH Terms

Interventions

Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

Cholecystectomy; Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures

Study Officials

• Luca Ansaloni, MD

  Fondazione IRCCS Policlinico San Matteo di Pavia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Ansaloni, MD

CONTACT

+390382502530; l.andaloni@smatteo.pv.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 9, 2025
• Study Start: October 20, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 9, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)