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NCT Number: NCT06918652

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

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.

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Key information

Conditions

High-risk Patients With Acute Calculous Cholecystitis (ACC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo

Pavia, 27100, Italy

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

    Time frame: baseline, pre-surgery, day 3

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

Secondary outcomes

  1. difference between the plasma concentration biochemical and immunological parameters

    Time frame: baseline, pre-surgery, day 1, day 3

    PTX (pentraxin-1, PCR), PTX2, PTX3, SAA (serum amyloid A) , PCT (procalcitonine), C3b, Pro-adrenomedullina, Cortisol, Hepcidin, TNFalpha, IL-1, IL-6, IL-8, IL-10 and IFNgamma, total WBC count, WBC subpopulation (neutrophils and total lymphocytes), T-helper lymphocytes (CD4), T-suppressor lymphocytes (CD8), natural killer lymphocytes (CD16 and CD56), pan B cell antigen (CD20), T-cell receptor gamma/delta, T reg, Th 17, human leukocyte antigen-DR (HLA-DR)

  2. 30-day postoperative complication rate according to Clavien-Dindo

    Time frame: day 30

    Rate of: biliary tree injury, hemorrhage, wound infection, deep infection (collections, abscesses), urinary tract infection, bowel perforation, biliary leakage, paralytic ileus, respiratory complication, cardiac complication, renal complication, cerebrovascular complication, thrombo-embolic complication, other

  3. 30-day postoperative biliary complication rate

    Time frame: day 30

    Rate of biliary leakage and main biliary duct injury

  4. 30-day postoperative mortality rate

    Time frame: day 30

    Mortality rate

  5. Intraoperative complication rate

    Time frame: day 0

    Rate of bleeding >500ml, Biliary tree injury, Bowel perforation, Major vascular injury, Anesthesia respiratory complications, Anesthesia cardiac complications, Other

  6. Failure rate of performing the procedure

    Time frame: day 0

    Rate of failure

  7. Operative times

    Time frame: through study completion, an average of 2 years

    • Procedure duration (measured from skin incision to skin closure for LC and from the introduction of the endoscope to its extraction for if TUGD with LAMSs) (minutes)
    • Time of occupation of the operating room (minutes)
    • Time from admission to the ED to the procedure (days)
    • rate of patients who used the prescribed painkiller "to need"
    • average of daily administrations of painkillers prescribed "to need" in the first post-procedure day
    • rate of patients where postoperative pain management therapy had to be varied compared to protocol

  8. Postoperative length of stay (PO-LOS)

    Time frame: through study completion, an average of 2 years

    Postoperative length of stay (days)

  9. Total length of stay (T-LOS)

    Time frame: through study completion, an average of 2 years

    Total length of stay (days)

  10. Total readmission rate within 6 months

    Time frame: 6 Months after procedure

    Readmission rate for all causes

  11. Readmission rate within 6 months due to Gallstones Relates Events (GRE)

    Time frame: 6 Months after procedure

    Readmission rate due to biliary colic, acute cholecystitis, acute pancreatitis, obstructive jaundice and cholangitis

  12. 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

    Outcomes of blood and bile cultures

  13. Post-operative pain

    Time frame: through study completion, an average of 2 years

    rate of patients who used the prescribed painkiller "to need"

    • average of daily administrations of painkillers prescribed "to need" in the first post-procedure day
    • rate of patients where postoperative pain management therapy had to be varied compared to protocol

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Ansaloni, MD

CONTACT

[email protected]

+390382502530

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Acronym: SETIMIHRACC

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.