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

NCT ID: NCT03463668

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-22

Study Completion Date

2029-12-31

Brief Summary

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

Detailed Description

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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?

Conditions

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Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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symptomatic non-covered duodenal prosthesis

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

uncovered metal duodenal prosthesis

Intervention Type DEVICE

Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis

Interventions

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uncovered metal duodenal prosthesis

Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fabrice CAILLOL

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli-Calmettes

Locations

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Institut Paoli Calmettes

Marseille, Bouches Du Rhone, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Fabrice CAILLOL

Role: CONTACT

0491223531

Jean-Philippe RATONE

Role: CONTACT

0491227727

Facility Contacts

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Dominique GENRE, MD

Role: primary

33 4 91 22 37 78

References

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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.

Reference Type BACKGROUND
PMID: 15015607 (View on PubMed)

Johnsson 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.

Reference Type BACKGROUND
PMID: 15457364 (View on PubMed)

Jeurnink 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.

Reference Type BACKGROUND
PMID: 17474082 (View on PubMed)

ASGE guidelines enteral stents

Reference Type BACKGROUND

Other Identifiers

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DYSPHAGIE-IPC 2017-036

Identifier Type: -

Identifier Source: org_study_id

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