NCT04672902

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

November 1, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

December 9, 2020

Last Update Submit

December 15, 2020

Conditions

Outcome Measures

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

    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

Interventions

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.

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • Patients older than 18 years old
  • Patients with a preoperative diagnosis of Mirizzi Syndrome
  • Patients with a common bile duct dilatation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escuela Nacional de Medicina, Tecnologico de Monterrey

Monterrey, Nuevo León, 76140, Mexico

Location

MeSH Terms

Conditions

Mirizzi SyndromeCholelithiasisCholecystitis, Acute

Condition Hierarchy (Ancestors)

CholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholecystitisGallbladder Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 17, 2020

Study Start

November 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Locations