Patients with benign recurrent and refractory esophageal anastomotic strictures.
Conditions
Interventions
Trade Name: Zuurstof medicinaal vloeibaar, Conoxia, 100% v/v, medicinaal gas, vloeibaar gemaakt
Pharmaceutical Form: Pressurised inhalation
Sponsors
University Medical Center Utrecht
Eligibility
Sex/Gender
All
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 - Last dilation =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this pilot study is to evaluate the effect of HBOT on recurrent and refractory esophageal anastomotic strictures. ;Secondary Objective: 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;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);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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): none;Timepoint(s) of evaluation of this end point: none | — |
Countries
Netherlands
Contacts
Public ContactTrial Bureau MDL
University Medical Center Utrecht
Outcome results
None listed