Polyp of ColonNCT04647266
Pronostic Score of Morbidity to Determine Risk of Complications After Endoscopic Submucosal Dissection for Colorectal Lesions
An observational study of Polyp of Colon, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%. Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polyp of Colon
- What is being tested?
- endoscopic submucosal dissection
- Type of treatment
- Surgery or procedure
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2016to 20 Nov 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient, more than 18 years old with no contra indication of the general anesthesia suffering of lesion relevant of endoscopic submucosal dissection treatment.
Who may be able to join
- Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:
- Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma
- Mucosal tumors with submucosal fibrosis
- Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis
- Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus
- Male or female patients aged ≥ 18 years old
- Patients able to fill in questionnaires written in French
Who cannot join
- Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays
The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.
Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.
There is currently no score established for the colo-rectal endoscopic submucosal dissection.
- To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
- Allow to obtain an estimation of number of patients required for a larger study.
- Conditions
- Polyp of Colon
- Being tested
- endoscopic submucosal dissection
- Keywords
- Endoscopic Submucosal Dissection
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic submucosal dissectionProcedure or surgery
endoscopic submucosal dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
Measured: From 2016 to 2020
Secondary outcomes (1)
Allow to obtain an estimation of number of patients required for a larger study
Measured: From 2016 to 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start16 Jun 2016
- Primary completion20 Nov 2020
- Study completion20 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polyp of ColonStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Baptiste CHEVAUX, Study director, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647266
- Sponsor's protocol ID
- 2019PI285
- Status last verified
- Nov 2020
- First submitted
- 23 Nov 2020
- Last updated
- 30 Nov 2020
- 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 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof of Concept for the Development of Clinical or Mixed Prognostic Score of Morbidity After Endoscopic Subcostal Dissection for Colorectal Lesions in Nancy's Hospital Since 2016 to Nowadays
- ClinicalTrials.gov ID
- NCT04647266
- Acronym / sponsor ID
- 2019PI285
- Conditions
- Polyp of Colon
- Keywords
- Endoscopic Submucosal Dissection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Nov 2020 (actual)
- First posted
- 30 Nov 2020 (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.
The mains complications in colo-rectal dissection are the pain, the delayed bleeding and the perforation and represent around 10%.
Currently, the procedure is realized during a hospitalization with not real recommendation about the time of this.
There is currently no score established for the colo-rectal endoscopic submucosal dissection.
- To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
- Allow to obtain an estimation of number of patients required for a larger study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient, more than 18 years old with no contra indication of the general anesthesia suffering of lesion relevant of endoscopic submucosal dissection treatment.
Key inclusion criteria (7 listed)
- Patient suffering of lesion relevant of endoscopic submucosal dissection treatment:
- Lesions for which en bloc resection with snare EMR is difficult to apply i/LST-NG, particularly LST-NG (PD) ii/ Lesions showing a VI-type pit pattern iii/ Carcinoma with shallow T1 (SM) invasion Large depressed-type tumors iv/ Large protruded-type lesions suspected to be carcinoma
- Mucosal tumors with submucosal fibrosis
- Sporadic tumors in conditions of chronic inflammation such as ulcerative colitis
- Local residual or recurrent early carcinomas after endoscopic resection Local res Les lésions de plus
Key exclusion criteria (1 listed)
- Suspicion of deep submucosal cancer by analysis of macroscopic appearance (Paris O-III), vascular pattern and pit pattern (SANO IIIB, KUDO Vn)
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 |
|---|---|---|
| endoscopic submucosal dissectionendoscopic submucosal dissection | Procedure or surgery | – |
Primary outcome
To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital.
Time frame: From 2016 to 2020
1 secondary outcome
Allow to obtain an estimation of number of patients required for a larger study
Time frame: From 2016 to 2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
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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.
Jean Baptiste CHEVAUX study director
Doctor
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 Polyp of Colon, run by Central Hospital, Nancy, France at 1 site in France.
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 7 inclusion and 1 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: finished, as of the sponsor's last update on 30 Nov 2020. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To develop clinical or mixed prognostic score after endoscopic subcostal dissection for colorectal lesions in Nancy's hospital. (time frame: From 2016 to 2020). 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 30 Nov 2020.