US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy (TROSELCII)

Attikon University Hospital

Status: Completed

Conditions: Cholecystitis

Treatments: Procedure: Seldinger percutaneous cholecystostomy; Procedure: Trocar percutaneous cholecystostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04602156

EBD 515/16-9-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Group T

Experimental group

Description:

Patients will be randomized to undergo PC catheter placement (8-French) using the trocar method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU.

Treatment:

Procedure: Trocar percutaneous cholecystostomy

Group S

Active Comparator group

Description:

Patients will be randomized to undergo PC catheter placement (8-French) using the Sellinger method under US guidance while receiving local anesthesia and opioid analgesic, in a bedside setting, either in the US room or in the ICU.

Treatment:

Procedure: Seldinger percutaneous cholecystostomy