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NCT Number: NCT03463668

Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years

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

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Key information

Conditions

Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis Digestive System Diseases Familial duodenal atresia Gastric Outlet Obstruction Gastrointestinal Diseases Pyloric Stenosis Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut Paoli Calmettes

Marseille, Bouches Du Rhone, 13009, France

Location status: Recruiting

Location contact

Dominique GENRE, MD

CONTACT

[email protected]

33 4 91 22 37 78

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

uncovered metal duodenal prosthesis

Device

Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis

Primary outcomes

  1. Dysphagia assessment

    Time frame: 7 years

    GOOSS = Gastric Outlet Obstruction Scoring System

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Fabrice CAILLOL

CONTACT

[email protected]

0491223531

Jean-Philippe RATONE

CONTACT

[email protected]

0491227727

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Registry information

Acronym: DYSPHAGIE

Important dates

Study start
2017
Primary completion
2029
Study completion
2029
First posted
Mar 13, 2018
Registry last updated
Mar 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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