Clinical Trials Directory

Trials / Completed

CompletedNCT02166957

Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique Foresophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus

Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique for Esophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus

Status
Completed
Phase
Study type
Observational
Enrollment
12 (actual)
Sponsor
Société Française d'Endoscopie Digestive · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Complete esophageal obstructions leads to definitive fasting. The rendez-vous endoscopic approach had already been described for complex stenoses but never for disruption with loss of tissue and SES. Patients and methods: This is a retrospective observationnal study about patients referred for complete esophageal disruption and classified in two groups: 1/ Long disruption (\> 5cm), after caustic ingestion or due to an esophageal stripping during SEMS removal; 2/ Short disruption (\< 5cm), consecutive to radiation therapy. All the procedures are performed according the anterograde retrograde approach, using CO2 and under X-rays guidance. We report the characteristeristics of the procedures, the efficacy, the time before discharge and refeeding, the complications, and the follow-up, especially the number of dilatation sessions for each group. The hypothesis is that anterograde retrograde endoscopic technique is safe and effective for the management of esophageal disruptions in patients for which the surgical treatment confers a high risk of morbidity and mortality.

Conditions

Interventions

TypeNameDescription
PROCEDURERecanalizationAll patients received clear and detailed information about the different steps, the benefits and the risks of the procedure they would undergo, and gave an informed consent. The rendez-vous technique shared some common characteristics whatever the etiology and the length of esophageal disruption. First, prior to start the specific endoscopic management, all the patients needed to have undergone a surgical gastrostomy one month earlier in order to allow the retrograde access. This one-month delay was necessary to get it completely healed before using it for the procedure. The principle of the combined anterograde retrograde approach is to get an endoscopic access to both the proximal and distal side of the obstruction in the purpose to achieve better and safer recanalization, which could be carried out with either transillumination or using a needle under x-rays guidance.

Timeline

Start date
2012-11-01
Primary completion
2015-09-01
Completion
2015-09-01
First posted
2014-06-18
Last updated
2015-11-25

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT02166957. Inclusion in this directory is not an endorsement.