US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

Cholecystitis Clinical Trial

— TROSELCII  

Official title:

Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602156
• Other study ID #: EBD 515/16-9-2020
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Cholecystitis

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