Viewing Study NCT04308993


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Study NCT ID: NCT04308993
Status: COMPLETED
Last Update Posted: 2020-03-16
First Post: 2020-03-06
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease
Sponsor: Imam Abdulrahman Bin Faisal University
Organization:

Study Overview

Official Title: Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study
Status: COMPLETED
Status Verified Date: 2020-03
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: None
Brief Summary: Patients with complex biliary stone disease are challenging to treat. The investigator present their experience in using urological interventions to treat challenging biliary stones.

Methods:

Fifteen patients with biliary calculi underwent 21 interventions using either extracorporeal shock wave lithotripsy (ESWL), percutaneous transhepatic choledochoscopy, percutaneous transcystic choledochoscopy, or a combination of these.
Detailed Description: The investigator conducted a retrospective review to investigate the outcomes of urological treatments for biliary calculi from January 1, 1999, to August 31, 2016, focusing on percutaneous endoscopic methods and/or ESWL. The primary outcomes of interest were symptom- and stone-free rates, length of hospital stay, and complications. Our institutional ethics review board approved the study (IRB-2018-01-119). Due to the retrospective nature of the study, the need for informed consent was waived. One endourologist evaluated all patients preoperatively.

Urological intervention techniques The three different approaches used (ESWL, PTHC, and PTCC) are described below.

Study Oversight

Has Oversight DMC: True
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?: