benign recurrent or refractory anastomotic strictures as a result of esophagectomy. Benign anastomic stricture esophagectomy Benigne anastomose strictuur oesofagectomie
Conditions
Interventions
Hyperbaric Oxygen Therapy in 30 sessions of 110 minutes at 2.5 atmospheres.
-The patient breathes 100% oxygen by a closed breathing apparatus (face mask or hood) inside a space (room) where the press
Sponsors
University Medical Center Utrecht
Eligibility
Inclusion criteria
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 within the last 12 months -Last dilation < 1 week before the start of hyperbaric oxygen therapy -Informed Consent
Exclusion criteria
Exclusion criteria: -Known or strongly suspected esophageal motility disorder -Known or strongly suspected malignant stricture -Non-anastomotic esophageal stricture -Contra indication for hyperbaric oxygen therapy: oUntreated pneumothorax oRestrictive treated pneumothorax (without thoraxdrain) oSevere respiratory diseases (COPD or pulmonary emphysema) oActive infection of the upper airways oRecent surgery of the middle ear oRecent thoracic surgery oUncontrolled high fever oEpilepsy oTreatment with pulmonary toxic medication (bleomycine, doxorubicin, adriamycin, amiodaron, furadantine) oPrevious treatment with bleomycine with pulmonary toxic reaction oKnown pregnancy or premenopausal woman that are not surgically sterile or taking oral contraceptives
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of hyperbaric oxygen therapy on the mucosal capillary hemoglobin oxygen saturation levels in the esophagus and the gastric tube | — |
Secondary
| Measure | Time frame |
|---|---|
| - To assess the effect of hyperbaric oxygen therapy on: - dysphagia symptoms - quality of life (QLQ-C30 + OES 18) | — |
Contacts
Public ContactW.F.W. Kappelle
P.O. box 85500 University Medical Center Utrecht Department of Gastroenterology & Hepatology Room F02.618
Outcome results
None listed