Esophageal DisruptionNCT02166957
Evaluation of the Effectiveness of Endoscopic "Rendez-vous" Technique Foresophageal Reconstructions for the Treatment of a Total and Extensive Disruption of the Esophagus
An observational study of Esophageal Disruption and Esophageal Obstruction, run by Société Française d'Endoscopie Digestive at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Disruption, Esophageal Obstruction
- What is being tested?
- Recanalization
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2012to Sep 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a retrospective report about six patients referred for complete esophageal disruption
Who may be able to join
- Esophageal disruption with or without loss of SES
Who cannot join
- Esophageal Complex stenosis
- Mediastinitis
- Severe sepsis
- Coagulation abnormalities
- Contra-indications to general anesthesia
Trial locations and contacts
1 site in 1 country.
France1 site
APHM, North Hospital, Department of gastroenterology
Marseille, 13915
About this study
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
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
- Being tested
- Recanalization
- Keywords
- Esophageal disruption, anterograde-retrograde endoscopy, rendez-vous technique, NOTES, recanalization, dilatations, Stenting, radiation therapy, head and neck carcinoma
- Medical subject headings
- Airway Obstruction, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RecanalizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Long disruption > 5cm +/- loss of SES | Not described Receives: Procedure: Recanalization | |
| Short disruption < 5cm | Not described Receives: Procedure: Recanalization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Secondary outcomes (4)
Number of endoscopic sessions
Measured: Up to 2 years
Time before refeeding
Measured: 15 days
Complications
Per-operative complications (bleeding, perforations, anesthesiological) and post-operative (infection, bleeding...)
Measured: 7 days
Number of endoscopic dilation sessions after recanalization
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startNov 2012
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal DisruptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VANBIERVLIET, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166957
- Sponsor's protocol ID
- OESORDV
- Other IDs
- OESORECO
- Status last verified
- Nov 2015
- First submitted
- 12 Jun 2014
- Last updated
- 25 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02166957
- Acronym / sponsor ID
- OESORDV
- Conditions
- Esophageal Disruption, Esophageal Obstruction
- Keywords
- Esophageal disruption, anterograde-retrograde endoscopy, rendez-vous technique, NOTES, recanalization, dilatations, Stenting, radiation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long disruption > 5cm +/- loss of SES | – | Procedure: Recanalization |
| Short disruption < 5cm | – | Procedure: Recanalization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a retrospective report about six patients referred for complete esophageal disruption
Key inclusion criteria (1 listed)
- Esophageal disruption with or without loss of SES
Key exclusion criteria (5 listed)
- Esophageal Complex stenosis
- Mediastinitis
- Severe sepsis
- Coagulation abnormalities
- Contra-indications to general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RecanalizationAll 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. | Procedure or surgery | Long disruption > 5cm +/- loss of SES, Short disruption < 5cm |
Primary outcome
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.
4 secondary outcomes
Number of endoscopic sessions
Time frame: Up to 2 years
Time before refeeding
Time frame: 15 days
Complications
Time frame: 7 days
Number of endoscopic dilation sessions after recanalization
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Disruption and Esophageal Obstruction, run by Société Française d'Endoscopie Digestive at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the rendez vous approach for treating esophageal disruption (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2015.