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OpenTrials
Completed

NCT Number: NCT04672902

Treatment of Mirizzi Syndrome

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.

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Key information

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Escuela Nacional de Medicina, Tecnologico de Monterrey

Monterrey, Nuevo León, 76140, Mexico

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single-operator cholangioscopy guided electrohydraulic lithotripsy

Procedure

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.

Primary outcomes

  1. Resolution of the common bile duct compression by an extrinsic gallbladder stone, with minimally invasive procedure such as single operator cholangioscopy, combined with lithotripsy

    Time frame: 2019-2020

    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.

Sponsors and collaborators

Lead sponsor

Tecnologico de Monterrey

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2020
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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