Colorectal NeoplasmsNCT05728710
Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection
An observational study of Colorectal Neoplasms and Perforation of Rectum, run by Central Hospital, Nancy, France at 13 sites in 2 countries.
Trial summary
Endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. En bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Perforation of Rectum, Perforation Colon
- What is being tested?
- Endoscopic submucosal dissection
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 13 sitesin 2 countries
- Study dates
- 1 Sep 2019to 1 Apr 2023
- How long will I take part?
- 48 Months
- 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: all adults patients identified from the FECCO (NCT04592003) cohort experciencing perprocedural or delayed perforation
Who may be able to join
- patients from the FECCO (NCT04592003) cohort experiencing perprocedural or delayed perforation
- age over 18 years old
Who cannot join
- patients refusing exploitations of health datas
- patient treated with endoscopic mucosal resection
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
France12 sites
Clinique Anjou
Angers
CHU Bordeaux
Bordeaux
CHU Dijon
Dijon
CHU Dupuytren
Limoges
Hopital Edouard Herriot
Lyon
Hopital Privé Jean Mermoz
Lyon
Nancy Hospital Center
Nancy, 54000
Clinique Jules Verne
Nantes
Hopital Europeen Georges Pompidou
Paris
Hôpital Cochin
Paris
Hôpital Saint Joseph
Paris
CHU de Rennes
Rennes
About this study
Endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. En bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. Endoscopic submucosal dissection (ESD) allows en bloc resection of large superficial colorectal neoplasms, increasing curative resection rate and decreasing local recurrence risk. However, the risk of perprocedural or delayed perforation is higher compared to wild field piece meal endoscopic mucosal resection. Endoscoping clipping and closing methods mostly allow conservative treatment, but some case still necessitate surgery. The aim of our study is to describe and ananalyse outcomes after perprocedural or delayed perforation in all patients undergoing ESD and analyse the need for surgical intervention.
- Being tested
- Endoscopic submucosal dissection
- Keywords
- endoscopic submucosal dissection, laterally spreading tumors, perforation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissectionProcedure or surgery
standard ESD performed and complicated with a perprocedural or delayed perforation
| Study group | Role | What they receive |
|---|---|---|
| Perforation | all patients with immediate or delayed perforation identified from the FECCO (NCT04592003) Receives: Procedure: Endoscopic submucosal dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery
Rate of surgery following perforation after ESD
Measured: 30 days
Secondary outcomes (6)
Hospital stay
length of hospital stay (days)
Measured: 60 days
Hospital readmission
Measured: 30 days
Curative resection rate
Measured: 60 days
Endoscopically closed perforation rate
Measured: 30 days
Risk factors for endoscopic closure failure
Measured: 30 days
30-days mortality rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Sep 2019
- Primary completion31 Mar 2023 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Prospective
- Enrolment
- 350 participants (actual)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marion SCHAEFER, Central Hospital, Nancy, France
- Investigators
- Marion Schaefer, MD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05728710
- Sponsor's protocol ID
- 2022PI178
- Status last verified
- Feb 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Perforation After Colorectal Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT05728710
- Acronym / sponsor ID
- 2022PI178
- Keywords
- endoscopic submucosal dissection, laterally spreading tumors, perforation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 15 Feb 2023 (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.
Endoscopic resection of superficial colorectal neoplasms decrease risk of colorectal cancer. En bloc resection is necessary for large superficial lesions with risk of superficial submucosal cancer and is advised if feasible for all lesions. Endoscopic submucosal dissection (ESD) allows en bloc resection of large superficial colorectal neoplasms, increasing curative resection rate and decreasing local recurrence risk. However, the risk of perprocedural or delayed perforation is higher compared to wild field piece meal endoscopic mucosal resection. Endoscoping clipping and closing methods mostly allow conservative treatment, but some case still necessitate surgery. The aim of our study is to describe and ananalyse outcomes after perprocedural or delayed perforation in all patients undergoing ESD and analyse the need for surgical intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perforation | – | Procedure: Endoscopic submucosal dissectionall patients with immediate or delayed perforation identified from the FECCO (NCT04592003) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all adults patients identified from the FECCO (NCT04592003) cohort experciencing perprocedural or delayed perforation
Key inclusion criteria (2 listed)
- patients from the FECCO (NCT04592003) cohort experiencing perprocedural or delayed perforation
- age over 18 years old
Key exclusion criteria (2 listed)
- patients refusing exploitations of health datas
- patient treated with endoscopic mucosal resection
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 dissectionstandard ESD performed and complicated with a perprocedural or delayed perforation | Procedure or surgery | Perforation |
Primary outcome
Surgery
Time frame: 30 days
Rate of surgery following perforation after ESD
6 secondary outcomes
Hospital stay
Time frame: 60 days
Hospital readmission
Time frame: 30 days
Curative resection rate
Time frame: 60 days
Endoscopically closed perforation rate
Time frame: 30 days
Risk factors for endoscopic closure failure
Time frame: 30 days
30-days mortality rate
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: No
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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.
Marion Schaefer, MD principal investigator
Central Hospital, Nancy, France
13 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms and Perforation of Rectum, run by Central Hospital, Nancy, France at 13 sites in 2 countries.
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 2 inclusion and 2 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 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France, Belgium. 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?
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?
Surgery (time frame: 30 days). 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 15 Feb 2023.