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

Completed

• Conditions: Esophageal Disruption; Esophageal Obstruction
• Interventions: Procedure: Recanalization

• Registration Number: NCT02166957
• Lead Sponsor: Société Française d'Endoscopie Digestive

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-06-12
• Study First Submitted QC: 2014-06-17
• Study First Posted: 2014-06-18
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-23
• Last Update Posted: 2015-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Short disruption < 5cm	Recanalization	-
Long disruption > 5cm +/- loss of SES	Recanalization	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of the rendez vous approach for treating esophageal disruption	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 Outcome Measures

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

Trial Locations

Locations (1)

APHM, North Hospital, Department of gastroenterology; 🇫🇷 Marseille, France