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

NCT02166957 | Completed DMC

• 2 other identifiers: OESORDVOESORECO
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Disruption; Esophageal Obstruction

Keywords

Esophageal disruption; anterograde-retrograde endoscopy; rendez-vous technique; NOTES; recanalization; dilatations; Stenting; radiation therapy; head and neck carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of endoscopic sessions

  Up to 2 years

• Time before refeeding

  15 days

• Complications

  7 days

• Number of endoscopic dilation sessions after recanalization

  Up to 2 years

Study Arms (2)

Long disruption > 5cm +/- loss of SES

Procedure: Recanalization

Short disruption < 5cm

Procedure: Recanalization

Interventions

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.

Long disruption > 5cm +/- loss of SES; Short disruption < 5cm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Esophageal disruption with or without loss of SES

You may not qualify if:

• Esophageal Complex stenosis
• Mediastinitis
• Severe sepsis
• Coagulation abnormalities
• Contra-indications to general anesthesia

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

Study Sites (1)

APHM, North Hospital, Department of gastroenterology

Marseille, 13915, France

Location

MeSH Terms

Conditions

Airway Obstruction; Dilatation, Pathologic

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: June 18, 2014
• Study Start: November 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 25, 2015

Record last verified: 2015-11

Locations

FR (1)