US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

Attikon Hospital100 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Cholecystitis

Interventions

Trocar percutaneous cholecystostomyPROCEDURE

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 cholecystostomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

"Attikon" University General Hospital

Athens, Attica, Greece

Outcomes

Primary Outcomes

Technical success

Image verified catheter placement within the gallbladder and subsequent bile aspiration

Time frame: At the end of the procedure

Procedure-related complications

Minor or major complications attributed to the procedure

Time frame: 3 months

Secondary Outcomes

Duration of the procedure

The time period between administration of local anesthesia and pigtail catheter positioning within the gallbladder

Time frame: Intraprocedural

Intraprocedural pain

pain experienced during the procedure assessed using a standard visual analogue score the procedure, as assessed using a standard visual analog score

Time frame: End of the procedure

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)

Time frame: 12 hours

Clinical success

Gradual subsidence of signs, symptoms, and elevated inflammatory markers

Time frame: 72 hours

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.