Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal StenosisDYSPHAGIENCT03463668
Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
An observational study of Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis, run by Institut Paoli-Calmettes at 1 site in France.
Trial summary
To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis
- What is being tested?
- uncovered metal duodenal prosthesis
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 22 Dec 2017to Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.
Who may be able to join
- Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.
Who cannot join
- Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Paoli Calmettes
Marseille, Bouches Du Rhone, 13009
Dominique GENRE, MD, 33 4 91 22 37 78, drci.up@ipc.unicancer.fr
About this study
To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia
Read the detailed description
Duodenal prostheses have become, since the 2000s, the first-line treatment of unresectable duodenal tumoral stenosis. The technical success is greater than 90%, however the endoscopic revisions that are duodenal or biliary are frequent. The IPC as a center of interventional endoscopy is very often in charge of these stenoses. We wanted to evaluate the efficiency and the duration of this effectiveness in current situation. Is there still room for gastrojejunal gastrojejunal surgery or for the development of endoscopic gastrojejunal anastomoses?
- Being tested
- uncovered metal duodenal prosthesis
- Keywords
- duodenal stenosis, pyloric stenosis, digestive neoplasias, non-digestive neoplasias, duodenal prosthesis
- Medical subject headings
- Familial duodenal atresia, Pyloric Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uncovered metal duodenal prosthesisDevice
Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis
| Study group | Role | What they receive |
|---|---|---|
| symptomatic non-covered duodenal prosthesis | Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017. Receives: Device: uncovered metal duodenal prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dysphagia assessment
GOOSS = Gastric Outlet Obstruction Scoring System
Measured: 7 years
Secondary outcomes (5)
Rate of complications
Rate of complications
Measured: 7 years
postoperative survival
defined as the time between the date of duodenal prosthesis insertion and the date of death or the latest news
Measured: 7 years
Permeability duration of the duodenal stent
defined as the time between the date of the laying of the duodenal stent and date of patient's death or RED or surgery (exceptional case) or latest news
Measured: 7 years
Rate of duodenal endoscopic resection at 1 and 3 months postoperatively
Rate of duodenal endoscopic resection at 1 and 3 months postoperatively
Measured: at 1 and 3 months postoperatively
Rate of biliary endoscopic resection at 1 and 3 months postoperatively
Rate of biliary endoscopic resection at 1 and 3 months postoperatively
Measured: at 1 and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start22 Dec 2017
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal StenosisStudies 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
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Paoli-Calmettes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabrice CAILLOL, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463668
- Sponsor's protocol ID
- DYSPHAGIE-IPC 2017-036
- Acronym
- DYSPHAGIE
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 13 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fiori E, Lamazza A, Volpino P, Burza A, Paparelli C, Cavallaro G, Schillaci A, Cangemi V. Palliative management of malignant antro-pyloric strictures. Gastroenterostomy vs. endoscopic stenting. A randomized prospective trial. Anticancer Res. 2004 Jan-Feb;24(1):269-71.
PubMed 15015607Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.
PubMed 15457364Jeurnink SM, Steyerberg EW, Hof Gv, van Eijck CH, Kuipers EJ, Siersema PD. Gastrojejunostomy versus stent placement in patients with malignant gastric outlet obstruction: a comparison in 95 patients. J Surg Oncol. 2007 Oct 1;96(5):389-96. doi: 10.1002/jso.20828.
PubMed 17474082ASGE guidelines enteral stents
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
- ClinicalTrials.gov ID
- NCT03463668
- Acronym / sponsor ID
- DYSPHAGIE / DYSPHAGIE-IPC 2017-036
- Keywords
- duodenal stenosis, pyloric stenosis, digestive neoplasias, non-digestive neoplasias, duodenal prosthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut Paoli-CalmettesUniversity, hospital or other
- Study start
- 22 Dec 2017 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 Mar 2018 (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.
To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia
Detailed description
Duodenal prostheses have become, since the 2000s, the first-line treatment of unresectable duodenal tumoral stenosis. The technical success is greater than 90%, however the endoscopic revisions that are duodenal or biliary are frequent. The IPC as a center of interventional endoscopy is very often in charge of these stenoses. We wanted to evaluate the efficiency and the duration of this effectiveness in current situation. Is there still room for gastrojejunal gastrojejunal surgery or for the development of endoscopic gastrojejunal anastomoses?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic non-covered duodenal prosthesis | – | Device: uncovered metal duodenal prosthesisAny symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.
Key inclusion criteria (1 listed)
- Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.
Key exclusion criteria (1 listed)
- Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)
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 |
|---|---|---|
| uncovered metal duodenal prosthesisImplantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis | Device | symptomatic non-covered duodenal prosthesis |
Primary outcome
Dysphagia assessment
Time frame: 7 years
GOOSS = Gastric Outlet Obstruction Scoring System
5 secondary outcomes
Rate of complications
Time frame: 7 years
postoperative survival
Time frame: 7 years
Permeability duration of the duodenal stent
Time frame: 7 years
Rate of duodenal endoscopic resection at 1 and 3 months postoperatively
Time frame: at 1 and 3 months postoperatively
Rate of biliary endoscopic resection at 1 and 3 months postoperatively
Time frame: at 1 and 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2018.
- Background: PubMed 15015607Fiori E, Lamazza A, Volpino P, Burza A, Paparelli C, Cavallaro G, Schillaci A, Cangemi V. Palliative management of malignant antro-pyloric strictures. Gastroenterostomy vs. endoscopic stenting. A randomized prospective trial. Anticancer Res. 2004 Jan-Feb;24(1):269-71.
- Background: PubMed 15457364Johnsson E, Thune A, Liedman B. Palliation of malignant gastroduodenal obstruction with open surgical bypass or endoscopic stenting: clinical outcome and health economic evaluation. World J Surg. 2004 Aug;28(8):812-7. doi: 10.1007/s00268-004-7329-0. Epub 2004 Aug 3.
- Background: PubMed 17474082Jeurnink SM, Steyerberg EW, Hof Gv, van Eijck CH, Kuipers EJ, Siersema PD. Gastrojejunostomy versus stent placement in patients with malignant gastric outlet obstruction: a comparison in 95 patients. J Surg Oncol. 2007 Oct 1;96(5):389-96. doi: 10.1002/jso.20828.
- BackgroundASGE guidelines enteral stents
- Individual participant dataSharing planned: No
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.
Fabrice CAILLOL 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 Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis, 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 1 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: looking for participants now, as of the sponsor's last update on 13 Mar 2018. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fabrice CAILLOL (0491223531, CAILLOLF@ipc.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dysphagia assessment (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03463668, which also lists 4 linked publications.
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 13 Mar 2018.