Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-30 @ 6:13 PM
Study NCT ID:
NCT04602156
Status:
COMPLETED
Last Update Posted:
2022-11-23
First Post:
2020-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
US-guided Trocar Versus Seldiger Technique for Percutaneous Cholecystostomy
Sponsor:
Attikon Hospital
Organization:
Study Overview
Official Title:
Randomized Comparison of US-guided TROcar Versus SELdiger Technique for Percutaneous Cholecystostomy. The TROSELC II Trial.
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TROSELCII
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: