The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease

NCT ID: NCT04149093

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-12-01

Brief Summary

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This study aims to compare the outcomes of patients with long segment Hirschsprung disease or total colonic aganglionosis who had negative calretinin staining and positive ganglion cells on the proximal resection margins to those who had both positive findings.

Detailed Description

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Conditions

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Hirschsprung Disease Ganglion Hirschsprung Disease, Long-Segment Hypoganglionosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Calretinin staining

A paraffin-embedded hematoxylinphloxin-safran sections will be performed on tissue specimens of proximal resection margins to evaluate the presence or absence of ganglion cells.

Immunohistochemistry (IHC) will then be done on paraffin-embedded sections for calretinin staining.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Immunohistochemistry

Eligibility Criteria

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Inclusion Criteria

* Confirmed histopathological diagnosis of Hirschsprung disease from January 1, 1990 to August 31, 2019
* Long-segment Hirschsprung disease (type A and B)
* Total colonic aganglionosis (TCA)
* Surgery at CHUSJ
* Tissue blocks of proximal resection margin available for pathological analysis
* Minimum 1 month of postoperative follow-up

Exclusion Criteria

* Short-segment Hirschsprung disease (conventional form, rectosigmoid junction)
* Total colonic with small bowel aganglionosis (TCSA)
* Surgery done at another institution
* Early deaths
* Lost to follow-up
* No documented post-operative outcome
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nelson Piche

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CHU Sainte-Justine

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Facility Contacts

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Annie Le-Nguyen, MD

Role: primary

5146929694

Other Identifiers

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2020-2597

Identifier Type: -

Identifier Source: org_study_id

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