Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease

Biliary Stones Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04308993
• Other study ID #: IAU-PEBE
• Status: Completed
• Start date: January 1, 1999
• Est. completion date: August 19, 2019

Study information

• Verified date: March 2020
• Source: Imam Abdulrahman Bin Faisal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 19, 2019
• Est. primary completion date: August 31, 2016
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• complete records

Exclusion Criteria:

• lost follow up

Related Conditions & MeSH terms

• Biliary Stones
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• percutaneous transhepatic choledochoscopy
percutaneous transhepatic choledochoscopy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Imam Abdulrahman Bin Faisal University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	obstructive jaundice	biochemical evidence (Liver function test) of improvement	one day
Primary	symptoms	success rate of biliary stone clearance or asymptomatic derbies	at least one year follow up
Secondary	ultrasound	evidence of stone clearance	one month