Treatment of Mirizzi Syndrome

Cholelithiasis Clinical Trial

Official title:

Single-operator Cholangioscopy and Electrohydraulic Lithotripsy for the Treatment of Mirizzi Syndrome: A Case Series

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672902
• Other study ID #: MS2012
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Mirizzi Syndrome
• Syndrome

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