Clinical trial NCT03463668: Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
Official title: Evaluation of the Efficacy of Duodenal Prostheses Not Covered Over 6 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis
Keywords: duodenal stenosis
pyloric stenosis
digestive neoplasias
non-digestive neoplasias
duodenal prosthesis
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any symptomatic duodenal stenosis with symptomatic duodenal duodenal prosthesis between 2010 and 2017.

Brief summary: 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?

Eligibility 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)

Primary outcomes:
measure: Dysphagia assessment
timeFrame: 7 years
Secondary outcomes:
measure: Rate of complications
timeFrame: 7 years
measure: postoperative survival
timeFrame: 7 years
measure: Permeability duration of the duodenal stent
timeFrame: 7 years
measure: Rate of duodenal endoscopic resection at 1 and 3 months postoperatively
timeFrame: at 1 and 3 months postoperatively
measure: Rate of biliary endoscopic resection at 1 and 3 months postoperatively
timeFrame: at 1 and 3 months postoperatively
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
state: Bouches Du Rhone
Study officials:
affiliation: Institut Paoli-Calmettes
name: Fabrice CAILLOL
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: ASGE guidelines enteral stents