Clinical trial NCT06330688: Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Official title: Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cholecystitis, Acute
Cholecystitis
Keywords: cholecystostomy
percutaneous
trocar
ultrasound
guided
technique
Seldinger
transhepatic
transperitoneal
subcostal
intercostal
technical
success
complications
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients requiring PC, irrespective of the underlying cause, comorbidities and indication, and irrespective of patient demographics.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* All patients requiring PC, irrespective of the underlying cause and indication, are suitable for inclusion in the study.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Technical success
timeFrame: Up to 1 hour
measure: Procedure-related complications
timeFrame: Up to 3 months
Secondary outcomes:
measure: duration of the procedure
timeFrame: Up to 1 hour
measure: intraprocedural and post-procedural pain
timeFrame: Up to 12 hours
measure: clinical success
timeFrame: Up to 72 hours
Other outcomes:
Locations:
city: Chaïdári
country: Greece
facility: Attikon University Hospital
state: Athens
Study officials:
References:
citation: 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.
citation: Arkoudis 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.
citation: Arkoudis 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.
citation: Reppas 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.