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

Study Overview
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Brief Summary
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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.

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

Conditions
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Esophageal Disruption, Esophageal Obstruction

Intervention / Treatment
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* Procedure: Recanalization


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Long disruption > 5cm +/- loss of SES<br> | Procedure: Recanalization<br>* 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.<br>|
| Short disruption < 5cm<br> | Procedure: Recanalization<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness of the rendez vous approach for treating esophageal disruption | We 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. | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of endoscopic sessions |  | Up to 2 years | 
| Time before refeeding |  | 15 days | 
| Complications | Per-operative complications (bleeding, perforations, anesthesiological) and post-operative (infection, bleeding...) | 7 days | 
| Number of endoscopic dilation sessions after recanalization |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Esophageal disruption, anterograde-retrograde endoscopy, rendez-vous technique, NOTES, recanalization, dilatations, Stenting, radiation therapy, head and neck carcinoma