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Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years (DYSPHAGIE)

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ClinicalTrials.gov Identifier: NCT03463668
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Institut Paoli-Calmettes

Brief Summary:
To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia

Condition or disease Intervention/treatment
Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis Device: uncovered metal duodenal prosthesis

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?

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : December 2029
Estimated Study Completion Date : December 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Artificial Limbs

Group/Cohort Intervention/treatment
symptomatic non-covered duodenal prosthesis
Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.
Device: uncovered metal duodenal prosthesis
Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis




Primary Outcome Measures :
  1. Dysphagia assessment [ Time Frame: 7 years ]
    GOOSS = Gastric Outlet Obstruction Scoring System


Secondary Outcome Measures :
  1. Rate of complications [ Time Frame: 7 years ]
    Rate of complications

  2. postoperative survival [ Time Frame: 7 years ]
    defined as the time between the date of duodenal prosthesis insertion and the date of death or the latest news

  3. Permeability duration of the duodenal stent [ Time Frame: 7 years ]
    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

  4. Rate of duodenal endoscopic resection at 1 and 3 months postoperatively [ Time Frame: at 1 and 3 months postoperatively ]
    Rate of duodenal endoscopic resection at 1 and 3 months postoperatively

  5. Rate of biliary 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.
Criteria

Inclusion Criteria:

  • Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.

Exclusion Criteria:

  • Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463668


Contacts
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Contact: Fabrice CAILLOL 0491223531 CAILLOLF@ipc.unicancer.fr
Contact: Jean-Philippe RATONE 0491227727 RATONEJ@ipc.unicancer.fr

Locations
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France
Institut Paoli Calmettes Recruiting
Marseille, Bouches Du Rhone, France, 13009
Contact: Dominique GENRE, MD    33 4 91 22 37 78    drci.up@ipc.unicancer.fr   
Sponsors and Collaborators
Institut Paoli-Calmettes
Investigators
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Principal Investigator: Fabrice CAILLOL Institut Paoli-Calmettes

Publications:
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Responsible Party: Institut Paoli-Calmettes
ClinicalTrials.gov Identifier: NCT03463668     History of Changes
Other Study ID Numbers: DYSPHAGIE-IPC 2017-036
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Paoli-Calmettes:
duodenal stenosis
pyloric stenosis
digestive neoplasias
non-digestive neoplasias
duodenal prosthesis
Additional relevant MeSH terms:
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Constriction, Pathologic
Neoplasms
Pathological Conditions, Anatomical