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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
80
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
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
SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, Italy
RECRUITINGThe 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
Time frame: baseline, pre-surgery, day 3
difference between the plasma concentration biochemical and immunological parameters
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)
Time frame: baseline, pre-surgery, day 1, day 3
30-day postoperative complication rate according to Clavien-Dindo
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
Time frame: day 30
30-day postoperative biliary complication rate
Rate of biliary leakage and main biliary duct injury
Time frame: day 30
30-day postoperative mortality rate
Mortality rate
Time frame: day 30
Intraoperative complication rate
Rate of bleeding \>500ml, Biliary tree injury, Bowel perforation, Major vascular injury, Anesthesia respiratory complications, Anesthesia cardiac complications, Other
Time frame: day 0
Failure rate of performing the procedure
Rate of failure
Time frame: day 0
Operative times
* 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
Time frame: through study completion, an average of 2 years
Postoperative length of stay (PO-LOS)
Postoperative length of stay (days)
Time frame: through study completion, an average of 2 years
Total length of stay (T-LOS)
Total length of stay (days)
Time frame: through study completion, an average of 2 years
Total readmission rate within 6 months
Readmission rate for all causes
Time frame: 6 Months after procedure
Readmission rate within 6 months due to Gallstones Relates Events (GRE)
Readmission rate due to biliary colic, acute cholecystitis, acute pancreatitis, obstructive jaundice and cholangitis
Time frame: 6 Months after procedure
Outcomes of blood and bile cultures (to define the infectious state of the patient)
Outcomes of blood and bile cultures
Time frame: Baseline, pre-surgery, during the surgery, day 1, day 3
Post-operative pain
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
Time frame: through study completion, an average of 2 years
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