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Completed

NCT Number: NCT04602156

US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

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

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Key information

Conditions

Cholecystitis Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Attikon" University General Hospital

Athens, Attica, 12461, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trocar percutaneous cholecystostomy

Procedure

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

Procedure

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.

Primary outcomes

  1. Technical success

    Time frame: At the end of the procedure

    Image verified catheter placement within the gallbladder and subsequent bile aspiration

  2. Procedure-related complications

    Time frame: 3 months

    Minor or major complications attributed to the procedure

Secondary outcomes

  1. Duration of the procedure

    Time frame: Intraprocedural

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

  2. Intraprocedural pain

    Time frame: 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

  3. Post-procedural pain

    Time frame: 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)

  4. Clinical success

    Time frame: 72 hours

    Gradual subsidence of signs, symptoms, and elevated inflammatory markers

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Acronym: TROSELCII

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 26, 2020
Registry last updated
Nov 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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