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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Laparoscopic cholecystectomy | Active Comparator | Patients randomized to control arm (LC) will receive laparoscopic cholecystectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transmural ultrasound-guided gallbladder drainage | Procedure | TUGD will be performed using the bi-flanged LAMSs mounted on an electrocautery-enhanced delivery system (Hot-AXIOSâ„¢) 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Ansaloni, MD | Contact | +390382502530 | l.andaloni@smatteo.pv.it |
| Name | Affiliation | Role |
|---|---|---|
| Luca Ansaloni, MD | Fondazione IRCCS Policlinico San Matteo di Pavia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo | Recruiting | Pavia | Pavia | 27100 | Italy |
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| 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 |
|
| 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 | day 30 |
| 30-day postoperative biliary complication rate | Rate of biliary leakage and main biliary duct injury | day 30 |
| 30-day postoperative mortality rate | Mortality rate | day 30 |
| Intraoperative complication rate | Rate of bleeding >500ml, Biliary tree injury, Bowel perforation, Major vascular injury, Anesthesia respiratory complications, Anesthesia cardiac complications, Other | day 0 |
| Failure rate of performing the procedure | Rate of failure | day 0 |
| Operative times |
| through study completion, an average of 2 years |
| Postoperative length of stay (PO-LOS) | Postoperative length of stay (days) | through study completion, an average of 2 years |
| Total length of stay (T-LOS) | Total length of stay (days) | through study completion, an average of 2 years |
| Total readmission rate within 6 months | Readmission rate for all causes | 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 | 6 Months after procedure |
| Outcomes of blood and bile cultures (to define the infectious state of the patient) | Outcomes of blood and bile cultures | Baseline, pre-surgery, during the surgery, day 1, day 3 |
| Post-operative pain | rate of patients who used the prescribed painkiller "to need"
| through study completion, an average of 2 years |
| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
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