US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

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Cholecystitis
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Brief Title

US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy

Official Title

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

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 Type

Interventional

Primary Outcome

Technical success

Secondary Outcome

 Duration of the procedure

Condition

Cholecystitis

Intervention

Trocar percutaneous cholecystostomy

Study Arms / Comparison Groups

 Group T
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

September 16, 2020

Completion Date

December 16, 2021

Primary Completion Date

September 16, 2021

Eligibility Criteria

        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

Gender

All

Ages

18 Years - 100 Years

Accepts Healthy Volunteers

No

Contacts

Stavros Spiliopoulos, MD, PhD, +302105831832, [email protected]

Location Countries

Greece

Location Countries

Greece

Administrative Informations

NCT ID

NCT04602156

Organization ID

EBD 515/16-9-2020

Responsible Party

Principal Investigator

Study Sponsor

Attikon Hospital

Study Sponsor

Stavros Spiliopoulos, MD, PhD, Principal Investigator, ATTIKO University Hospital

Verification Date

December 2020