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

March 12, 2018 updated by: Institut Paoli-Calmettes
To assess the efficacy of duodenal prostheses for duodenal stenosis established for endoscopic pyloric or duodenal stenosis on dysphagia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Bouches Du Rhone
      • Marseille, Bouches Du Rhone, France, 13009
        • Recruiting
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dysphagia assessment
Time Frame: 7 years
GOOSS = Gastric Outlet Obstruction Scoring System
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of complications
Time Frame: 7 years
Rate of complications
7 years
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
7 years
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
7 years
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
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
Rate of biliary endoscopic resection at 1 and 3 months postoperatively
at 1 and 3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Investigators

  • Principal Investigator: Fabrice CAILLOL, Institut Paoli-Calmettes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2017

Primary Completion (Anticipated)

December 1, 2029

Study Completion (Anticipated)

December 1, 2029

Study Registration Dates

First Submitted

March 5, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DYSPHAGIE-IPC 2017-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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