High-risk Patients With Acute Calculous Cholecystitis (ACC)SETIMIHRACCNCT06918652
Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
A study testing Transmural ultrasound-guided gallbladder drainage and Laparoscopic cholecystectomy in people with High-risk Patients With Acute Calculous Cholecystitis (ACC), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-risk Patients With Acute Calculous Cholecystitis (ACC)
- What is being tested?
- Transmural ultrasound-guided gallbladder drainage and Laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
SC Chirurgia Generale 1 - Fondazione IRCCS Policlinico San Matteo
Pavia, Pavia, 27100
About this study
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.
- Being tested
- Transmural ultrasound-guided gallbladder drainage, Laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmural ultrasound-guided gallbladder drainageProcedure or surgery
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 cholecystectomyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Transmural ultrasound-guided gallbladder drainage |
| Laparoscopic cholecystectomy | Active comparator | Patients randomized to control arm (LC) will receive laparoscopic cholecystectomy. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, pre-surgery, day 3
Secondary outcomes (13)
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)
Measured: 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
Measured: day 30
30-day postoperative biliary complication rate
Rate of biliary leakage and main biliary duct injury
Measured: day 30
30-day postoperative mortality rate
Mortality rate
Measured: day 30
Intraoperative complication rate
Rate of bleeding >500ml, Biliary tree injury, Bowel perforation, Major vascular injury, Anesthesia respiratory complications, Anesthesia cardiac complications, Other
Measured: day 0
Failure rate of performing the procedure
Rate of failure
Measured: 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
Measured: through study completion, an average of 2 years
Postoperative length of stay (PO-LOS)
Postoperative length of stay (days)
Measured: through study completion, an average of 2 years
Total length of stay (T-LOS)
Total length of stay (days)
Measured: through study completion, an average of 2 years
Total readmission rate within 6 months
Readmission rate for all causes
Measured: 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
Measured: 6 Months after procedure
Outcomes of blood and bile cultures (to define the infectious state of the patient)
Outcomes of blood and bile cultures
Measured: 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
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start20 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-risk Patients With Acute Calculous Cholecystitis (ACC)Studies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Ansaloni, Fondazione IRCCS Policlinico San Matteo di Pavia
- Investigators
- Luca Ansaloni, MD, Principal investigator, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918652
- Sponsor's protocol ID
- SETIMIHRACC
- Acronym
- SETIMIHRACC
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical vs Endoscopic Treatments as ImmunoModulating Interventions in High-Risk Acute Calculous Cholecystitis
- ClinicalTrials.gov ID
- NCT06918652
- Acronym / sponsor ID
- SETIMIHRACC / SETIMIHRACC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transmural ultrasound-guided gallbladder drainage | Experimental | Procedure: Transmural ultrasound-guided gallbladder drainagePatients randomized to TUGD arm will receive endoscopic transmural ultrasound-guided gallbladder drainage with lumen-apposing self-expandable metal stents (LAMSs) |
| Laparoscopic cholecystectomy | Active comparator | Procedure: Laparoscopic cholecystectomyPatients randomized to control arm (LC) will receive laparoscopic cholecystectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transmural ultrasound-guided gallbladder drainageTUGD 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 | Procedure or surgery | Transmural ultrasound-guided gallbladder drainage |
| Laparoscopic cholecystectomyLC 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 | Procedure or surgery | Laparoscopic cholecystectomy |
Primary outcome
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
13 secondary outcomes
difference between the plasma concentration biochemical and immunological parameters
Time frame: baseline, pre-surgery, day 1, day 3
30-day postoperative complication rate according to Clavien-Dindo
Time frame: day 30
30-day postoperative biliary complication rate
Time frame: day 30
30-day postoperative mortality rate
Time frame: day 30
Intraoperative complication rate
Time frame: day 0
Failure rate of performing the procedure
Time frame: day 0
Operative times
Time frame: through study completion, an average of 2 years
Postoperative length of stay (PO-LOS)
Time frame: through study completion, an average of 2 years
Total length of stay (T-LOS)
Time frame: through study completion, an average of 2 years
Total readmission rate within 6 months
Time frame: 6 Months after procedure
Readmission rate within 6 months due to Gallstones Relates Events (GRE)
Time frame: 6 Months after procedure
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
Post-operative pain
Time frame: through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for High-risk Patients With Acute Calculous Cholecystitis (ACC)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luca Ansaloni, MD principal investigator
Fondazione IRCCS Policlinico San Matteo di Pavia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transmural ultrasound-guided gallbladder drainage and Laparoscopic cholecystectomy in people with High-risk Patients With Acute Calculous Cholecystitis (ACC), run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luca Ansaloni, MD (+390382502530, l.andaloni@smatteo.pv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.