US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

Not Applicable

Completed

• Conditions: Cholecystitis
• Interventions: Procedure: Seldinger percutaneous cholecystostomy; Procedure: Trocar percutaneous cholecystostomy

• Registration Number: NCT04602156
• Lead Sponsor: Attikon Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-09-16
• Study First Submitted: 2020-10-20
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-26
• Status Verified: 2022-11
• Primary Completion: 2022-11-22
• Study Completion: 2022-11-22
• Last Update Submitted: 2022-11-22
• Last Update Posted: 2022-11-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group S	Seldinger percutaneous cholecystostomy	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.
Group T	Trocar percutaneous cholecystostomy	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.

Primary Outcome Measures

Name	Time	Method
Technical success	At the end of the procedure	Image verified catheter placement within the gallbladder and subsequent bile aspiration
Procedure-related complications	3 months	Minor or major complications attributed to the procedure

Secondary Outcome Measures

Name	Time	Method
Clinical success	72 hours	Gradual subsidence of signs, symptoms, and elevated inflammatory markers
Duration of the procedure	Intraprocedural	The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder
Intraprocedural pain	End of the procedure	pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score
Post-procedural pain	12 hours	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)

Trial Locations

Locations (1)

"Attikon" University General Hospital; 🇬🇷 Athens, Attiki, Greece