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

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.

Study Overview

• Status: Completed
• Conditions: Esophageal Obstruction; Esophageal Disruption
• Intervention / Treatment: Procedure: Recanalization

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13915
    • APHM, North Hospital, Department of gastroenterology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a retrospective report about six patients referred for complete esophageal disruption

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Long disruption > 5cm +/- loss of SES	Procedure: 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.
Short disruption < 5cm	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Société Française d'Endoscopie Digestive

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 12, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Estimate): November 25, 2015
• Last Update Submitted That Met QC Criteria: November 23, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: radiation therapy; NOTES; recanalization; Stenting; head and neck carcinoma; Esophageal disruption; anterograde-retrograde endoscopy; rendez-vous technique; dilatations
• Other Study ID Numbers: OESORDV; OESORECO