Prospective Evaluation of Ultrasound-guided Percutaneous Cholecystostomy With the Trocar Technique
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cholecystitis, Acute
- Sponsor
- Attikon Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Technical success
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Stavros Spiliopoulos
Associate Professor of Diagnostic and Interventional Radiology
Attikon Hospital
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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
- duration of the procedure(Up to 1 hour)
- intraprocedural and post-procedural pain(Up to 12 hours)
- clinical success(Up to 72 hours)