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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04602156
Other study ID # EBD 515/16-9-2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2020
Est. completion date November 22, 2022

Study information

Verified date November 2022
Source Attikon Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A single-center randomized comparison of bedside ultrasound (US)-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy


Description:

This is a single-center, randomized, controlled trial (RCT), comparing bedside US-guided trocar technique versus the US-guided Seldinger technique for percutaneous cholecystostomy (PC). The study will randomize a total of 100 consecutive patients (50 in each group) undergoing PC at one large tertiary university hospital. The primary endpoints will be technical success and procedure-related complication rates. Secondary endpoints will be procedural duration, pain assessment, and clinical success after up to 3 months of follow-up.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date November 22, 2022
Est. primary completion date November 22, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - All patients requiring PC, regardless of the underlying cause. - Signed informed consent form Exclusion Criteria: - Age <18 years or >100 years - The necessity for CT-guided PC catheter placement, according to the judgment of the performing physician - Severe uncontrollable coagulopathy

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Trocar percutaneous cholecystostomy
Percutaneous cholecystostomy using the one-step Trocar technique under US guidance. An 8Fr Trocar catheter will be inserted percutaneously within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.
Seldinger percutaneous cholecystostomy
Percutaneous cholecystostomy using the Seldinger technique under US guidance. Following percutaneous puncture of the gallbladder with an 18G needle under real-time US guidance, an 8Fr catheter will be inserted percutaneously over the wire within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.

Locations

Country Name City State
Greece "Attikon" University General Hospital Athens Attiki

Sponsors (1)

Lead Sponsor Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary Technical success Image verified catheter placement within the gallbladder and subsequent bile aspiration At the end of the procedure
Primary Procedure-related complications Minor or major complications attributed to the procedure 3 months
Secondary Duration of the procedure The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder Intraprocedural
Secondary Intraprocedural pain pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score End of the procedure
Secondary Post-procedural pain Pain experienced up to12 hours after procedure assessed using a standard visual analogue score (VAS - Visual Analog Scale 0-10, 0 representing no pain & 10 representing worst pain experienced) 12 hours
Secondary Clinical success Gradual subsidence of signs, symptoms, and elevated inflammatory markers 72 hours
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