E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with benign recurrent and refractory esophageal anastomotic strictures. |
Patienten met een benigne, terugkerende of therapierefractaire esophageale anastomotische stenose |
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E.1.1.1 | Medical condition in easily understood language |
Patients with benign recurrent and refractory esophageal anastomotic strictures. |
Patienten met een goedaardige, terugkerende of niet op behandeling reagerende vernauwing van de slokdarm na een buismaag reconstructie. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The overall objective of this pilot study is to evaluate the effect of HBOT on recurrent and refractory esophageal anastomotic strictures. |
Het doel van deze pilot studie is het evalueren van het effect van hyperbare zuurstof therapie voor terugkerende of therapie resistente esophageale anastomotische stenosen. |
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E.2.2 | Secondary objectives of the trial |
To assess the effect of HBOT on the mean dysphagia free period, as compared with the period prior to starting HBOT, the number of interventions for recurrence of the anastomotic stricture ,the number of patients who are dyspahgia free until six months after start of HBOT, quality of life |
Het evalueren van het effect van HBOT op gemiddelde dysfagie vrije periode, aantal interventies ivm terugkeer van anastomose strictuur, aantal patienten dat dysfagie vrij is tot 6 maanden na start van HBOT, kwaliteit van lever |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Benign esophageal anastomotic stricture; defined as a stenosis at the esophagogastric anastomosis causing clinically significant dysphagia. - Clinically significant dysphagia; defined as grade 2 or worse on the Ogilvie scale - First presentation of dysphagia due to the stricture within 6 months after surgery - Recurrent or refractory stricture: > 5 previous dilation sessions for this indication - Last dilation < 1 week before the start of HBOT - Informed Consent
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- Goedaardige anastomotische stenose van de slokdarm; gedefineerd als een stenose ter plaatse van de slokdarm-maag overgang die klinisch relevante dysfagie klachten veroorzaakt. - Klinisch significante dysfagie klachten; gedefineerd als een graad 2 of erger op de Ogilvie schaal - Eerste presentatie van dysfagieklachten door de strenose binnen 6 maanden na de operatie. - Terugkerende of tehrapie resistente stenose: > 5 eerdere dilatatie sessies voor deze indicatie - Laatste dilatie < 1 week voor start HBOT - Informed Consent
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E.4 | Principal exclusion criteria |
- Known or strongly suspected esophageal motility disorder - Known or strongly suspected malignant stricture - Non-anastomotic stricture - Contra indication for HBOT: o Untreated pneumothorax o Restrictive treated pneumothorax (without thoraxdrain) o Severe respiratory diseases (COPD or pulmonary emphysema) o Active infection of the upper airways o Recent surgery of the middle ear o Recent thoracic surgery o Uncontrolled high fever o Severe epilepsy o Treatment with pulmonary toxic medication (bleomycine, doxorubicin, adriamycin, amiodaron, furadantine) o Previous treatment with bleomycine with pulmonary toxic reaction o Known pregnancy or premenopausal woman that are not surgically sterile or taking oral contraceptives |
- Bekende of hoge verdenking voor een motiliteitsstoornis van de slokdarm - Bekende of hoge verdenking voor een maligne stenose - Niet anastomotische strictuur - Contra indicatie voor HBOT: o Onbehandelde pneumothorax o Restrictief behandelde pneumothorax (zonder thoraxdrain) o Ernstige longziekten (COPD of longemfyseem) o Actieve infectie van de bovenste luchtwegen o Recente operatie van het middenoor o Recente thoracale chirurgie o Uncontroleerbare hoge koorts o Ernstige epilepsy o Behandeling met pneumotoxische medicatie(bleomycine, doxorubicine, adriamycine, amiodaronen, furadantine) o Eerdere behandeling met bleomycine met longtoxiciteit o Bekende zwangerschap of premenopauzale vrouwen die niet chirurgische steriel zijn of orale anticonceptie gebruiken. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary -The effect of HBOT on the mean dysphagia free period, as compared with the period prior to starting HBOT.
Secondary -The number of reinterventions for recurrence of the anastomotic stricture -The number of patients who are dysphagia until six months after the start of HBOT -Quality of life (QLQ-C30 + OES 18) |
-Het effect van HBOT op gemiddelde dysfagie vrije periode, in vergelijking met periode voor start HBOT -aantal interventies voor terugkeer anastomose strictuur -aantal patienten dat dysfagie vrij is tot 6 maanden na start HBOT -kwaliteit van leven (QLQ-C30 + OES 18) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. At baseline and after HBOT (=6 weeks) 2. At 2 weeks and monthly thereafter untill 6 months FU 3. Baseline, after HBOT and after 6 months |
1. Baseline en na 6 weken (=einde HBOT) 2. Na 2 weken en daarna maandelijks tot 6 maanden follow up 3. gemeten op moment van inclusie, na HBOT en na 6 maanden |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |