Hirschsprung DiseaseNCT04149093
The Association Between Calretinin and the Function of Ganglion Cells in Hirschsprung Disease
An observational study of Hirschsprung Disease and Ganglion, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 years to 18 months
- Conditions the study is for
- Hirschsprung Disease, Ganglion, Hirschsprung Disease, Long-Segment
- What is being tested?
- Calretinin staining
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2020to 1 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Patients with Hirschsprung disease and a transition zone more proximal to the distal sigmoid
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Annie Le-Nguyen, MD, 5146929694, annie.le-nguyen@outlook.com
About this study
Official title: The Association Between Calretinin and the Function of Ganglion Cells in Long Segment and Total Hirschsprung Disease
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.
- Being tested
- Calretinin staining
- Medical subject headings
- Hirschsprung Disease, Ganglion Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calretinin stainingDiagnostic test
Also called Immunohistochemistry
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term outcomes (Quality of life questionnaire)
To determine if calretinin has a role in the function of ganglion cells in long segment Hirschsprung disease and total colonic aganglionosis.
HAQL (Hirschsprung's disease and Anorectal malformations Quality of Life) questionnaire. For each item the response is scored from 0 to 3 and then, linearly transformed to a 0 (minimum value) to 100 (maximum value) scale. Higher score suggests a better quality of life.
Measured: 1 year
Secondary outcomes (2)
Surgical complications
- Number of reoperations
- Number of rebiopsies
- Number of readmissions
- Number of bowel obstructions
- Number of bowel perforation
- Number of anastomotic leaks
- Number of anastomotic strictures
- Number of fistula
- Number of anal stenosis
- Number of Hirschsprung-associated enterocolitis
Measured: 1 year
Functional outcomes
- Presence of constipation (yes/no)
- Presence of diarrhea (yes/no)
- Presence of incontinence and soiling (yes/no)
- Presence of abdominal distension (yes/no)
- Presence of dependance on enemas/medications (yes/no)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start1 May 2020
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hirschsprung DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nelson Piche, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04149093
- Sponsor's protocol ID
- 2020-2597
- Status last verified
- Mar 2021
- First submitted
- 23 Oct 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Calretinin and the Function of Ganglion Cells in Long Segment and Total Hirschsprung Disease
- ClinicalTrials.gov ID
- NCT04149093
- Acronym / sponsor ID
- 2020-2597
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 years to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with Hirschsprung disease and a transition zone more proximal to the distal sigmoid
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calretinin stainingAlso: ImmunohistochemistryA 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. | Diagnostic test | – |
Primary outcome
Long-term outcomes (Quality of life questionnaire)
Time frame: 1 year
To determine if calretinin has a role in the function of ganglion cells in long segment Hirschsprung disease and total colonic aganglionosis. HAQL (Hirschsprung's disease and Anorectal malformations Quality of Life) questionnaire. For each item the response is scored from 0 to 3 and then, linearly transformed to a 0 (minimum value) to 100 (maximum value) scale. Higher score suggests a better quality of life.
2 secondary outcomes
Surgical complications
Time frame: 1 year
Functional outcomes
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hirschsprung Disease and Ganglion, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Long-term outcomes (Quality of life questionnaire) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.