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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02166957
Enrollment
12
Registered
2014-06-18
Start date
2012-11-30
Completion date
2015-09-30
Last updated
2015-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Disruption, Esophageal Obstruction

Keywords

Esophageal disruption, anterograde-retrograde endoscopy, rendez-vous technique, NOTES, recanalization, dilatations, Stenting, radiation therapy, head and neck carcinoma

Brief 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.

Interventions

PROCEDURERecanalization

All 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.

Sponsors

Société Française d'Endoscopie Digestive
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Esophageal disruption with or without loss of SES

Exclusion criteria

* Esophageal Complex stenosis * Mediastinitis * Severe sepsis * Coagulation abnormalities * Contra-indications to general anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Effectiveness of the rendez vous approach for treating esophageal disruption2 daysWe evaluate the technical and the clinical success. The technical success is the ability to recanalize the esophagus endoscopically. The clnical success is the possibility to feed patients.

Secondary

MeasureTime frameDescription
Number of endoscopic sessionsUp to 2 years
Time before refeeding15 days
Complications7 daysPer-operative complications (bleeding, perforations, anesthesiological) and post-operative (infection, bleeding...)
Number of endoscopic dilation sessions after recanalizationUp to 2 years

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026