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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04672902
Other study ID # MS2012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2020
Est. completion date December 1, 2020

Study information

Verified date December 2020
Source Tecnologico de Monterrey
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Mirizzi syndrome is an infrequent complication of long-standing cholelithiasis. Extrinsic compression of the common hepatic duct is usually caused by an impacted stone in Hartmann's pouch or cystic duct resulting in the development of cholecystobiliary fistula. This syndrome is classified based on the presence and severity of cholecystobiliary fistula. Mirizzi syndrome is challenging to diagnose preoperatively and may require complex biliary surgical procedures for resolution. Endoscopic treatment is a safe alternative with a high success rate. Single-operator cholangioscopy combined with lithotripsy has been shown to have a 90-100% success rate in the treatment of biliary stones. Herein, A single center experience treating Mirizzi syndrome with single-operator cholangioscopy guided electrohydraulic lithotripsy is presented. Difficult management of Mirizzi syndrome has led to research of new treatment options to minimize the risk of high rate complications. Single-operator cholangioscopy in combination with laser lithotripsy is an adequate and safe alternative for the treatment of this condition.


Recruitment information / eligibility

Status Completed
Enrollment 3
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - Patients older than 18 years old - Patients with a preoperative diagnosis of Mirizzi Syndrome - Patients with a common bile duct dilatation Exclusion Criteria: - Patients younger than 18 years old - Patients with an inconclusive biliary diagnosis - Patients without a diagnosis of Mirrizi Syndrome - Patients without common bile duct dilatation

Study Design


Intervention

Procedure:
Single-operator cholangioscopy guided electrohydraulic lithotripsy
Single-operator cholangioscopy guided electrohydraulic lithotripsy has the advantage of providing direct visualization of the bile ducts, enabling a single physician to diagnose and perform the therapeutic intervention in a single procedure.

Locations

Country Name City State
Mexico Escuela Nacional de Medicina, Tecnologico de Monterrey Monterrey Nuevo Leon

Sponsors (1)

Lead Sponsor Collaborator
Tecnologico de Monterrey

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of the common bile duct compression by an extrinsic gallbladder stone, with minimally invasive procedure such as single operator cholangioscopy, combined with lithotripsy Single operator cholangioscopy, combined with lithotripsy, will be use for treating patients with Mirizzi syndrome, while avoiding open surgery, and subsequent lesions to the biliary ducts. Post surgical morbidity will be assessed. 2019-2020
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