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

Esophageal Obstruction Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02166957
• Other study ID #: OESORDV
• Secondary ID: OESORECO
• Status: Completed
• Phase: N/A
• First received: June 12, 2014
• Last updated: November 23, 2015
• Start date: November 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Société Française d'Endoscopie Digestive
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité Consultatif National d'Ethique
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Esophageal Disruption
• Esophageal Obstruction
• Esophageal Stenosis

Intervention

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.

Locations

Country	Name	City	State
France	APHM, North Hospital, Department of gastroenterology	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Société Française d'Endoscopie Digestive

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of endoscopic sessions		Up to 2 years	No
Secondary	Time before refeeding		15 days	Yes
Secondary	Complications	Per-operative complications (bleeding, perforations, anesthesiological) and post-operative (infection, bleeding...)	7 days	Yes
Secondary	Number of endoscopic dilation sessions after recanalization		Up to 2 years	No