Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique

Cholecystitis Clinical Trial

Official title:

Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330688
• Other study ID #: ??? 53/25.01.2024
• Status: Recruiting
• Start date: March 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Attikon Hospital
• Contact: Stavros Spiliopoulos, MD, PhD, Associate Professor
• Phone: +302105831812
• Email: stavspiliop[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

Procedure:
• percutaneous cholecystostomy
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.

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Chaïdári	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

References & Publications (4)

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 (N — View 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. Epu — View 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. — View 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 Cholecysto — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Image verification of correct PC catheter placement within the gallbladder lumen with subsequent bile aspiration at the time of initial catheter placement	Up to 1 hour
Primary	Procedure-related complications	Complications attributed to the procedure	Up to 3 months
Secondary	duration of the procedure	The time passed from local anesthesia administration until final pigtail catheter positioning within the gallbladder lumen	Up to 1 hour
Secondary	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').	Up to 12 hours
Secondary	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)	Up to 72 hours