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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

NCT ID: NCT02166957

Last Updated: 2015-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2015-09-30

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.

Detailed Description

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Conditions

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Esophageal Disruption Esophageal Obstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Long disruption > 5cm +/- loss of SES

Recanalization

Intervention Type PROCEDURE

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.

Short disruption < 5cm

Recanalization

Intervention Type PROCEDURE

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.

Interventions

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Recanalization

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.

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Société Française d'Endoscopie Digestive

OTHER

Sponsor Role lead

Responsible Party

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VANBIERVLIET

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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APHM, North Hospital, Department of gastroenterology

Marseille, , France

Site Status

Countries

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France

Other Identifiers

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OESORECO

Identifier Type: -

Identifier Source: secondary_id

OESORDV

Identifier Type: -

Identifier Source: org_study_id