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

Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis Clinical Trial

— DYSPHAGIE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03463668
• Other study ID #: DYSPHAGIE-IPC 2017-036
• Status: Recruiting
• Phase: N/A
• First received: March 5, 2018
• Last updated: March 12, 2018
• Start date: December 22, 2017
• Est. completion date: December 2029

Study information

• Verified date: March 2018
• Source: Institut Paoli-Calmettes
• Contact: Fabrice CAILLOL
• Phone: 0491223531
• Email: CAILLOLF[@]ipc.unicancer.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2029
• Est. primary completion date: December 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis
• Neoplasms

Intervention

Device:
• uncovered metal duodenal prosthesis
Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille	Bouches Du Rhone

Sponsors (1)

Lead Sponsor	Collaborator
Institut Paoli-Calmettes

Country where clinical trial is conducted

France, 

References & Publications (4)

ASGE guidelines enteral stents

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. — View 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. — View 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. Epub 2004 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dysphagia assessment	GOOSS = Gastric Outlet Obstruction Scoring System	7 years
Secondary	Rate of complications	Rate of complications	7 years
Secondary	postoperative survival	defined as the time between the date of duodenal prosthesis insertion and the date of death or the latest news	7 years
Secondary	Permeability duration of the duodenal stent	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
Secondary	Rate of duodenal endoscopic resection at 1 and 3 months postoperatively	Rate of duodenal endoscopic resection at 1 and 3 months postoperatively	at 1 and 3 months postoperatively
Secondary	Rate of biliary endoscopic resection at 1 and 3 months postoperatively	Rate of biliary endoscopic resection at 1 and 3 months postoperatively	at 1 and 3 months postoperatively