Percutaneous Endoscopic Biliary Exploration in Complex Biliary Stone Disease

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

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.

Study Overview

• Status: Completed
• Conditions: Biliary Stones
• Intervention / Treatment: Procedure: percutaneous transhepatic choledochoscopy

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 Type: Observational
• Enrollment (Actual): 15

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Most patients were elderly (median age, 60 years). The male-to-female ratio was higher than the norm for biliary stones (1:1.4). The most common reasons for failure of conventional endoscopic retrograde cholangiopancreatography (ERCP) were high American Society of Anesthesia (ASA) score (8 patients 53%), technical failure of ERCP (4 patients, 27%), previous Roux-en-Y gastric bypass (two patients, 13%), and post-common bile duct (CBD) injury with T-tube insertion (one patient, 7%). The stone sites were the CBD, gallbladder, and intrahepatic bile duct in nine (60%), three (20%), and three (20%) patients, respectively

Description

Inclusion Criteria:

• complete records

Exclusion Criteria:

• lost follow up

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
symptoms	success rate of biliary stone clearance or asymptomatic derbies	at least one year follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ultrasound	evidence of stone clearance	one month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
obstructive jaundice	biochemical evidence (Liver function test) of improvement	one day

Collaborators and Investigators

• Sponsor: Imam Abdulrahman Bin Faisal University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1999
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 19, 2019

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Gallbladder Diseases; Biliary Tract Diseases; Calculi; Gallstones; Cholelithiasis; Cholecystolithiasis
• Other Study ID Numbers: IAU-PEBE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No