Colorectal AdenomaHYBRID ESDNCT02935049
Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique
An observational study of Colorectal Adenoma and Intramucinous Adenocarcinoma, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenoma, Intramucinous Adenocarcinoma
- What is being tested?
- Endoscopic resection
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Oct 2018
- 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: Patients with colorectal adenoma or intramucinous adenocarcinoma
Who may be able to join
- Age > 18 years,
- Patient with colorectal adenoma or intramucinous adenocarcinoma
Who cannot join
- Contraindication surgery
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GENRE
Marseille, 13273
GENRE Dominique, MD, +33 (4) 91 22 37 78, drci.up@ipc.unicancer.fr
COURNIER Sandra, Project Manager, +33 (4) 91 22 37 78, courniers@ipc.unicancer.fr
About this study
For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)
- Conditions
- Colorectal Adenoma, Intramucinous Adenocarcinoma
- Being tested
- Endoscopic resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
Endoscopic resection with technique EMR piecemeal or hybrid technique EMR/ESD
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse rate
Medical follow-up
Measured: From surgery to 1 year
Secondary outcomes (1)
Complications rate
haemorrhage or perforation
Measured: From surgery to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2017 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenomaStudies of the same condition, open and under way.
- More trials run by Institut Paoli-CalmettesThe 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- RATONE Jean Philippe, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935049
- Sponsor's protocol ID
- HYBRID ESD-IPC 2016-015
- Acronym
- HYBRID ESD
- Status last verified
- Oct 2017
- First submitted
- 13 Oct 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Resection of Adenoma and Colic Adenocarcinoma by EMR Piecemeal or EMR/ESD Hybrid Technique
- ClinicalTrials.gov ID
- NCT02935049
- Acronym / sponsor ID
- HYBRID ESD / HYBRID ESD-IPC 2016-015
- Conditions
- Colorectal Adenoma, Intramucinous Adenocarcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- 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.
For tough colic resection, evaluation of our practice for these lesions unresectable in monoblock and evaluation of the contribution of the hybrid technique EMR (mucosectomy dissection) /ESD (submucosal dissection)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colorectal adenoma or intramucinous adenocarcinoma
Key inclusion criteria (2 listed)
- Age > 18 years,
- Patient with colorectal adenoma or intramucinous adenocarcinoma
Key exclusion criteria (1 listed)
- Contraindication surgery
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 resectionEndoscopic resection with technique EMR piecemeal or hybrid technique EMR/ESD | Procedure or surgery | – |
Primary outcome
Relapse rate
Time frame: From surgery to 1 year
Medical follow-up
1 secondary outcome
Complications rate
Time frame: From surgery to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- Institut Paoli-CalmettesLink provided by the sponsor.
- 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.
RATONE Jean Philippe, MD principal investigator
Institut Paoli-Calmettes
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 Colorectal Adenoma and Intramucinous Adenocarcinoma, run by Institut Paoli-Calmettes 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 2 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: status not confirmed, as of the sponsor's last update on 26 Oct 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GENRE Dominique, MD (+33 (4) 91 22 37 78, drci.up@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse rate (time frame: From surgery to 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 26 Oct 2017.