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Completed

NCT Number: NCT02166957

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

APHM, North Hospital, Department of gastroenterology

Marseille, 13915, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recanalization

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.

Primary outcomes

  1. Effectiveness of the rendez vous approach for treating esophageal disruption

    Time frame: 2 days

    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.

Secondary outcomes

  1. Number of endoscopic sessions

    Time frame: Up to 2 years

  2. Time before refeeding

    Time frame: 15 days

  3. Complications

    Time frame: 7 days

    Per-operative complications (bleeding, perforations, anesthesiological) and post-operative (infection, bleeding...)

  4. Number of endoscopic dilation sessions after recanalization

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jun 18, 2014
Registry last updated
Nov 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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