Cholecystitis, AcuteNCT06330688
Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
An observational study of Cholecystitis, Acute and Cholecystitis, run by Attikon Hospital at 1 site in Greece.
Trial summary
The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute, Cholecystitis
- What is being tested?
- percutaneous cholecystostomy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2024to Jun 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: All patients requiring PC, irrespective of the underlying cause, comorbidities and indication, and irrespective of patient demographics.
Who may be able to join
- All patients requiring PC, irrespective of the underlying cause and indication, are suitable for inclusion in the study.
Who cannot join
- Patients are going to be excluded from the study if they are younger than 18 years, if they require PC catheter placement under CT guidance (according to the operator's judgement), or if they suffer from severe uncontrollable coagulopathy.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Attikon University Hospital
Chaïdári, Athens, 12461
Stavros Spiliopoulos, MD, Associate Professor, +302105831812, stavspiliop@gmail.com
About this study
The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside.
Read the detailed description
This clinical study will include patients who will undergo US-guided PC with the trocar technique. The study will include all cases requiring PC regardless of the underlying cause, while those requiring computed tomography (CT) guidance and those with uncontrolled coagulation disorders will be excluded.
Patient demographics, height, weight, and body mass index (BMI), comorbidities, ASA score, presence or absence of stones, presence or absence of gallbladder perforation at diagnosis, presence or absence of concomitant ascitic effusion, days of preoperative antibiotic treatment, imaging modality used to establish the diagnosis, technical details of the procedure, laboratory values (before and after surgery), and contact information for patient monitoring will be recorded.
The technical success of the method as well as its complications during hospitalization and during a 3-month follow-up period will be calculated. In addition, the anatomical access route during the PC (transhepatic/transperitoneal and intercostal/subcostal), the duration of the operation, the intraoperative and postoperative pain, and the clinical success of the method will be recorded.
After the operation, the patients will be monitored clinically and with laboratory test and, if deemed necessary, US, CT or both imaging will be performed. Before discharge, written instructions will be given regarding the management and care of the catheter.
This study will not burden the hospital financially, as the clinical, laboratory, and imaging tests required for the diagnosis of the underlying etiology that leads to the need to perform the procedure, the technique used to perform the procedure, as well as the monitoring of the patients and the possible complications of the procedure, are part of the hospital's routine.
- Conditions
- Cholecystitis, Acute, Cholecystitis
- Being tested
- percutaneous cholecystostomy
- Keywords
- cholecystostomy, percutaneous, trocar, ultrasound, guided, technique, Seldinger, transhepatic, transperitoneal, subcostal, intercostal, technical, success, complications
- Medical subject headings
- Cholecystitis, Acute, Cholecystitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous cholecystostomyProcedure or surgery
PC is a minimally invasive, nonsurgical, image-guided intervention that aims to drain and decompress the gallbladder by placing a pigtail catheter through the abdominal wall into the gallbladder lumen.
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success
Image verification of correct PC catheter placement within the gallbladder lumen with subsequent bile aspiration at the time of initial catheter placement
Measured: Up to 1 hour
Procedure-related complications
Complications attributed to the procedure
Measured: Up to 3 months
Secondary outcomes (3)
duration of the procedure
The time passed from local anesthesia administration until final pigtail catheter positioning within the gallbladder lumen
Measured: Up to 1 hour
intraprocedural and post-procedural pain
pain experienced during and up to 12 h after the procedure according to the VAS (Visual Analog Scale). The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Measured: Up to 12 hours
clinical success
The subsidence of signs, symptoms and elevated inflammatory markers up to 72 h after PC (Subsidence of Murphy's sign, pain or tenderness in the right upper quadrant, fever, leukocytosis, elevated C-reactive protein)
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stavros Spiliopoulos, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330688
- Sponsor's protocol ID
- ΕΒΔ 53/25.01.2024
- Status last verified
- Mar 2024
- First submitted
- 22 Feb 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arkoudis NA, Moschovaki-Zeiger O, Reppas L, Grigoriadis S, Alexopoulou E, Brountzos E, Kelekis N, Spiliopoulos S. Percutaneous cholecystostomy: techniques and applications. Abdom Radiol (NY). 2023 Oct;48(10):3229-3242. doi: 10.1007/s00261-023-03982-2. Epub 2023 Jun 20.
PubMed 37338588Arkoudis NA, Reppas L, Spiliopoulos S. Image-guided percutaneous cholecystostomy: challenging the norms. Abdom Radiol (NY). 2024 Mar;49(3):939-941. doi: 10.1007/s00261-023-04173-9. Epub 2024 Jan 31.
PubMed 38294540Arkoudis NA, Moschovaki-Zeiger O, Grigoriadis S, Palialexis K, Reppas L, Filippiadis D, Alexopoulou E, Brountzos E, Kelekis N, Spiliopoulos S. US-guided trocar versus Seldinger technique for percutaneous cholecystostomy (TROSELC II trial). Abdom Radiol (NY). 2023 Jul;48(7):2425-2433. doi: 10.1007/s00261-023-03916-y. Epub 2023 Apr 20.
PubMed 37081229Reppas L, Arkoudis NA, Spiliopoulos S, Theofanis M, Kitrou PM, Katsanos K, Palialexis K, Filippiadis D, Kelekis A, Karnabatidis D, Kelekis N, Brountzos E. Two-Center Prospective Comparison of the Trocar and Seldinger Techniques for Percutaneous Cholecystostomy. AJR Am J Roentgenol. 2020 Jan;214(1):206-212. doi: 10.2214/AJR.19.21685. Epub 2019 Oct 1.
PubMed 31573856
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
- ClinicalTrials.gov ID
- NCT06330688
- Acronym / sponsor ID
- ΕΒΔ 53/25.01.2024
- Conditions
- Cholecystitis, Acute, Cholecystitis
- Keywords
- cholecystostomy, percutaneous, trocar, ultrasound, guided, technique, Seldinger, transhepatic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 26 Mar 2024 (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.
The purpose of this study is to further evaluate and investigate the safety and efficacy of ultrasound (US)-guided percutaneous cholecystostomy (PC) with the trocar technique by the patient's bedside.
Detailed description
This clinical study will include patients who will undergo US-guided PC with the trocar technique. The study will include all cases requiring PC regardless of the underlying cause, while those requiring computed tomography (CT) guidance and those with uncontrolled coagulation disorders will be excluded.
Patient demographics, height, weight, and body mass index (BMI), comorbidities, ASA score, presence or absence of stones, presence or absence of gallbladder perforation at diagnosis, presence or absence of concomitant ascitic effusion, days of preoperative antibiotic treatment, imaging modality used to establish the diagnosis, technical details of the procedure, laboratory values (before and after surgery), and contact information for patient monitoring will be recorded.
The technical success of the method as well as its complications during hospitalization and during a 3-month follow-up period will be calculated. In addition, the anatomical access route during the PC (transhepatic/transperitoneal and intercostal/subcostal), the duration of the operation, the intraoperative and postoperative pain, and the clinical success of the method will be recorded.
After the operation, the patients will be monitored clinically and with laboratory test and, if deemed necessary, US, CT or both imaging will be performed. Before discharge, written instructions will be given regarding the management and care of the catheter.
This study will not burden the hospital financially, as the clinical, laboratory, and imaging tests required for the diagnosis of the underlying etiology that leads to the need to perform the procedure, the technique used to perform the procedure, as well as the monitoring of the patients and the possible complications of the procedure, are part of the hospital's routine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients requiring PC, irrespective of the underlying cause, comorbidities and indication, and irrespective of patient demographics.
Key inclusion criteria (1 listed)
- All patients requiring PC, irrespective of the underlying cause and indication, are suitable for inclusion in the study.
Key exclusion criteria (1 listed)
- Patients are going to be excluded from the study if they are younger than 18 years, if they require PC catheter placement under CT guidance (according to the operator's judgement), or if they suffer from severe uncontrollable coagulopathy.
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 |
|---|---|---|
| percutaneous cholecystostomyPC is a minimally invasive, nonsurgical, image-guided intervention that aims to drain and decompress the gallbladder by placing a pigtail catheter through the abdominal wall into the gallbladder lumen. | Procedure or surgery | – |
Primary outcome
Technical success
Time frame: Up to 1 hour
Image verification of correct PC catheter placement within the gallbladder lumen with subsequent bile aspiration at the time of initial catheter placement
Procedure-related complications
Time frame: Up to 3 months
Complications attributed to the procedure
3 secondary outcomes
duration of the procedure
Time frame: Up to 1 hour
intraprocedural and post-procedural pain
Time frame: Up to 12 hours
clinical success
Time frame: Up to 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Results publication: PubMed 37338588Arkoudis NA, Moschovaki-Zeiger O, Reppas L, Grigoriadis S, Alexopoulou E, Brountzos E, Kelekis N, Spiliopoulos S. Percutaneous cholecystostomy: techniques and applications. Abdom Radiol (NY). 2023 Oct;48(10):3229-3242. doi: 10.1007/s00261-023-03982-2. Epub 2023 Jun 20.
- Results publication: PubMed 38294540Arkoudis NA, Reppas L, Spiliopoulos S. Image-guided percutaneous cholecystostomy: challenging the norms. Abdom Radiol (NY). 2024 Mar;49(3):939-941. doi: 10.1007/s00261-023-04173-9. Epub 2024 Jan 31.
- Results publication: PubMed 37081229Arkoudis NA, Moschovaki-Zeiger O, Grigoriadis S, Palialexis K, Reppas L, Filippiadis D, Alexopoulou E, Brountzos E, Kelekis N, Spiliopoulos S. US-guided trocar versus Seldinger technique for percutaneous cholecystostomy (TROSELC II trial). Abdom Radiol (NY). 2023 Jul;48(7):2425-2433. doi: 10.1007/s00261-023-03916-y. Epub 2023 Apr 20.
- Results publication: PubMed 31573856Reppas L, Arkoudis NA, Spiliopoulos S, Theofanis M, Kitrou PM, Katsanos K, Palialexis K, Filippiadis D, Kelekis A, Karnabatidis D, Kelekis N, Brountzos E. Two-Center Prospective Comparison of the Trocar and Seldinger Techniques for Percutaneous Cholecystostomy. AJR Am J Roentgenol. 2020 Jan;214(1):206-212. doi: 10.2214/AJR.19.21685. Epub 2019 Oct 1.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholecystitis, Acute and Cholecystitis, run by Attikon Hospital at 1 site in Greece.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Mar 2024. 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 Greece. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stavros Spiliopoulos, MD, PhD, Associate Professor (+302105831812, stavspiliop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success (time frame: Up to 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06330688, which also lists 4 linked publications.
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 26 Mar 2024.