Duodenal AdenomaMUCO-DUONCT03031704
French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy
An observational study of Duodenal Adenoma, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Duodenal Adenoma
- What is being tested?
- Endoscopic mucosectomy
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2017to 9 Jan 2022
- How long will I take part?
- 24 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: Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included
Who may be able to join
- Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy
Who cannot join
- patients with previous endoscopic resection,
- patients prsenting lesion involving the major papilla, sub mucosal lesions
- patient with familial adenomatous polyposis
- patient undergoing use of antiplatelet agent during the five last days
Trial locations and contacts
1 site in 1 country.
Philippe GRANDVAL, MD/PhD contact
France1 site, 1 recruiting
- Recruiting
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Philippe Grandval, MD/PhD, philippe.grandval@ap-hm.fr
About this study
Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than that can be observed for colorectal adenomas. As no prospective data have been published this French multicenter study aim to analyze results of this technique under standardized and secured procedure.
All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly expected among the international society of gastroenterologists who need to confirm the efficacy of endoscopy and define optimal conditions for performing adenomas resection in this location Primary End Point is the two years recurrence rate. Secondary End Points are frequency and type of complication after standardized endoscopic mucosectomy of duodenal adenomas, frequency and type of complications after a second endoscopic mucosectomy and patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions, familial adenomatous polyposis and use of antiplatelet agent during the five last days.
Hundred and twenty patients will be included and followed 2 years after mucosectomy.
- Conditions
- Duodenal Adenoma
- Being tested
- Endoscopic mucosectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic mucosectomyProcedure or surgery
Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic mucosectomy | Not described Receives: Procedure: Endoscopic mucosectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of recurrence after surgery
Measured: 2 yeras
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start9 Jan 2017
- Primary completion9 Jan 2021 (estimated)
- Study completion9 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duodenal AdenomaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031704
- Sponsor's protocol ID
- 2016-27
- Acronym
- MUCO-DUO
- Status last verified
- Jan 2017
- First submitted
- 23 Jan 2017
- Last updated
- 26 Jan 2017
- 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 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- French Register of Duodenal Adenomas Characterization and Evaluation of Endoscopic Mucosectomy
- ClinicalTrials.gov ID
- NCT03031704
- Acronym / sponsor ID
- MUCO-DUO / 2016-27
- Conditions
- Duodenal Adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- 9 Jan 2021 (estimated)
- Study completion
- 9 Jan 2022 (estimated)
- First posted
- 26 Jan 2017 (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.
Sporadic duodenal adenomas are rare. As they are highly pre neoplastic, they should be removed and endoscopic mucosectomy is recommended during digestive endoscopy. However, this technique, albeit less dangerous than surgery, is associated with complications such as haemorrhages, perforations, and more relapse than that can be observed for colorectal adenomas. As no prospective data have been published this French multicenter study aim to analyze results of this technique under standardized and secured procedure.
All investigators are expert in therapeutic endoscopy in tertiary centers and are member of a group of clinical researcher involved in that field (" GRAPHE " (Groupe de Recherche et d'Action des Praticiens Hospitaliers en Endoscopie interventionnelle). Results are highly expected among the international society of gastroenterologists who need to confirm the efficacy of endoscopy and define optimal conditions for performing adenomas resection in this location Primary End Point is the two years recurrence rate. Secondary End Points are frequency and type of complication after standardized endoscopic mucosectomy of duodenal adenomas, frequency and type of complications after a second endoscopic mucosectomy and patient's characteristics Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included. Non-inclusion criteria concern patients with previous endoscopic resection, lesion involving the major papilla, sub mucosal lesions, familial adenomatous polyposis and use of antiplatelet agent during the five last days.
Hundred and twenty patients will be included and followed 2 years after mucosectomy.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic mucosectomy | – | Procedure: Endoscopic mucosectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy will be included
Key inclusion criteria (1 listed)
- Patients with sporadic duodenal adenomas larger than 5 mm requiring endoscopic mucosectomy
Key exclusion criteria (4 listed)
- patients with previous endoscopic resection,
- patients prsenting lesion involving the major papilla, sub mucosal lesions
- patient with familial adenomatous polyposis
- patient undergoing use of antiplatelet agent during the five last days
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 mucosectomyPerforming adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma. | Procedure or surgery | Endoscopic mucosectomy |
Primary outcome
Number of recurrence after surgery
Time frame: 2 yeras
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2017.
- 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.
Philippe GRANDVAL, MD/PhD contact
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
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 Duodenal Adenoma, run by Assistance Publique Hopitaux De Marseille 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 1 inclusion and 4 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 Jan 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 Philippe GRANDVAL, MD/PhD (philippe.grandval@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of recurrence after surgery (time frame: 2 yeras). 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 Jan 2017.