ClinicalTrials.gg
RecruitingNCT03463668DYSPHAGIEUpdated Mar 13, 2018

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

An observational study in Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis, sponsored by Institut Paoli-Calmettes. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Institut Paoli-Calmettes · Observational

From the registry’s dates

  • Started Dec 2017; still recruiting 8 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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?

02

Conditions studied

  • Digestive or Non-digestive Neoplasia Leading to Symptomatic Duodenal Stenosis

Browse trials for

Keywords

  • duodenal stenosis
  • pyloric stenosis
  • digestive neoplasias
  • non-digestive neoplasias
  • duodenal prosthesis
03

In context

Pyloric Stenosis

9 studies on the registry are indexed under Pyloric Stenosis; 1 is open to participants now.

Browse Pyloric Stenosis studies →

Lead sponsor

Institut Paoli-Calmettes is the lead sponsor of 172 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Benign stenosis or covered metallic duodenal prosthesis (usually indicated for benign disease)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • symptomatic non-covered duodenal prosthesis

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

    Device: uncovered metal duodenal prosthesis

Interventions

  • Deviceuncovered metal duodenal prosthesis

    Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis

06

What researchers measure

Primary outcomes

  1. Dysphagia assessment

    GOOSS = Gastric Outlet Obstruction Scoring System

    Time frame: 7 years

Secondary outcomes

  1. Rate of complications

    Rate of complications

    Time frame: 7 years

  2. postoperative survival

    defined as the time between the date of duodenal prosthesis insertion and the date of death or the latest news

    Time frame: 7 years

  3. 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

    Time frame: 7 years

  4. Rate of duodenal endoscopic resection at 1 and 3 months postoperatively

    Rate of duodenal endoscopic resection at 1 and 3 months postoperatively

    Time frame: at 1 and 3 months postoperatively

  5. Rate of biliary endoscopic resection 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 15015607 ↗
  • 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. PubMed 15457364 ↗
  • 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. PubMed 17474082 ↗
  • ASGE guidelines enteral stents

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Dec 2017 (actual). Primary completion is estimated for Dec 2029, 144 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2018
First posted
Mar 13, 2018
StartActual
Dec 22, 2017
Primary completionEst.
Dec 2029
CompletionEst.
Dec 2029
Last update
Mar 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03463668
Responsible party
Sponsor
First posted
Mar 13, 2018
Start date
Dec 22, 2017
Primary completion
Dec 2029 (estimated)
Completion
Dec 2029 (estimated)
Last update
Mar 13, 2018

Study contacts

Fabrice CAILLOL
Contact
CAILLOLF@ipc.unicancer.fr
0491223531
Jean-Philippe RATONE
Contact
RATONEJ@ipc.unicancer.fr
0491227727
Fabrice CAILLOL
principal investigator · Institut Paoli-Calmettes

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion