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

March 19, 2024 updated by: Stavros Spiliopoulos, Attikon Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Stavros Spiliopoulos, MD, PhD, Associate Professor
  • Phone Number: +302105831812
  • Email: stavspiliop@gmail.com

Study Contact Backup

Study Locations

  • Greece
    • Athens
      • Chaïdári, Athens, Greece, 12461
        • Recruiting
        • Attikon University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients requiring PC, irrespective of the underlying cause, comorbidities and indication, and irrespective of patient demographics.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 hour
Procedure-related complications
Time Frame: Up to 3 months
Complications attributed to the procedure
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the procedure
Time Frame: Up to 1 hour
The time passed from local anesthesia administration until final pigtail catheter positioning within the gallbladder lumen
Up to 1 hour
intraprocedural and post-procedural pain
Time Frame: Up to 12 hours
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
clinical success
Time Frame: Up to 72 hours
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Attikon Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

February 22, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ΕΒΔ 53/25.01.2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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