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OpenTrials
Completed

NCT Number: NCT04308993

Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

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

Inclusion criteria

  • complete records

Exclusion criteria

  • lost follow up

Treatment and study plan

percutaneous transhepatic choledochoscopy

Procedure

percutaneous transhepatic choledochoscopy

Other names: extracorporeal shock wave lithotripsy (ESWL)

Primary outcomes

  1. symptoms

    Time frame: at least one year follow up

    success rate of biliary stone clearance or asymptomatic derbies

Secondary outcomes

  1. ultrasound

    Time frame: one month

    evidence of stone clearance

Other outcomes

  1. obstructive jaundice

    Time frame: one day

    biochemical evidence (Liver function test) of improvement

Sponsors and collaborators

Lead sponsor

Imam Abdulrahman Bin Faisal University

Other

Registry information

Official study title

Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease: Cohort Study

Important dates

Study start
1999
Primary completion
2016
Study completion
2019
First posted
Mar 16, 2020
Registry last updated
Mar 16, 2020

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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