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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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

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Cholecystitis, Acute Cholecystitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No