- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04672902
Treatment of Mirizzi Syndrome
December 15, 2020 updated by: Tecnologico de Monterrey
Single-operator Cholangioscopy and Electrohydraulic Lithotripsy for the Treatment of Mirizzi Syndrome: A Case Series
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nuevo Leon
-
Monterrey, Nuevo Leon, Mexico, 76140
- Escuela Nacional de Medicina, Tecnologico de Monterrey
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 46 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
A 34-year-old female, A 54-year-old male, A 40-year-old female.
with diagnosed Mirizzi Syndrome by an image study, with a concomitant common bile duct dilatation.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2019-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Actual)
December 1, 2020
Study Registration Dates
First Submitted
December 9, 2020
First Submitted That Met QC Criteria
December 15, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 15, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS2012
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on Single-operator cholangioscopy guided electrohydraulic lithotripsy
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AdventHealthCompleted
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-
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-
Asian Institute of Gastroenterology, IndiaUnknownCholangitis | Obstructive JaundiceIndia
-
University of Sao Paulo General HospitalBoston Scientific CorporationUnknownCholedocholithiasis | Common Bile Duct GallstonesBrazil
-
Seoul National University HospitalRecruitingLiver Transplant; Complications | Biliary Duct Obstruction | Anastomosis, ObstructedKorea, Republic of
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Sunnybrook Health Sciences CentreUnknownPatients With Difficult Vascular Access.