High-risk Patients With Acute Calculous Cholecystitis (ACC)
Conditions
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.
Interventions
PROCEDURETransmural 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
PROCEDURELaparoscopic 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
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day postoperative complication rate according to Clavien-Dindo | 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 |
| 30-day postoperative biliary complication rate | day 30 | Rate of biliary leakage and main biliary duct injury |
| 30-day postoperative mortality rate | day 30 | Mortality rate |
| Intraoperative complication rate | day 0 | Rate of bleeding \>500ml, Biliary tree injury, Bowel perforation, Major vascular injury, Anesthesia respiratory complications, Anesthesia cardiac complications, Other |
| Failure rate of performing the procedure | day 0 | Rate of failure |
| Operative times | 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 |
| difference between the plasma concentration biochemical and immunological parameters | 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) |
| Total length of stay (T-LOS) | through study completion, an average of 2 years | Total length of stay (days) |
| Total readmission rate within 6 months | 6 Months after procedure | Readmission rate for all causes |
| Readmission rate within 6 months due to Gallstones Relates Events (GRE) | 6 Months after procedure | Readmission rate due to biliary colic, acute cholecystitis, acute pancreatitis, obstructive jaundice and cholangitis |
| Outcomes of blood and bile cultures (to define the infectious state of the patient) | Baseline, pre-surgery, during the surgery, day 1, day 3 | Outcomes of blood and bile cultures |
| Post-operative pain | 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 |
| Postoperative length of stay (PO-LOS) | through study completion, an average of 2 years | Postoperative length of stay (days) |
Countries
Italy
Contacts
Primary ContactLuca Ansaloni, MD
Outcome results
None listed