NCT04308993

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 1999

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1999

Completed
17.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2016

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

17.7 years

First QC Date

March 6, 2020

Last Update Submit

March 12, 2020

Conditions

Biliary Stones

Outcome Measures

Primary Outcomes (1)

  • symptoms

    success rate of biliary stone clearance or asymptomatic derbies

    at least one year follow up

Secondary Outcomes (1)

  • ultrasound

    one month

Other Outcomes (1)

  • obstructive jaundice

    one day

Interventions

percutaneous transhepatic choledochoscopyPROCEDURE

percutaneous transhepatic choledochoscopy

Also known as: extracorporeal shock wave lithotripsy (ESWL)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • complete records

You may not qualify if:

  • lost follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cholecystolithiasis

Interventions

Lithotripsy

Condition Hierarchy (Ancestors)

CholelithiasisBiliary Tract DiseasesDigestive System DiseasesGallbladder Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsUltrasonic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Surgery

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 16, 2020

Study Start

January 1, 1999

Primary Completion

August 31, 2016

Study Completion

August 19, 2019

Last Updated

March 16, 2020

Record last verified: 2020-03