Hyperbaric oxygen therapy for benign strictures after esophageal surgery: a pilot study

Conditions: Patients with benign recurrent and refractory esophageal anastomotic strictures.
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2013-000603-16-NL

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Known or strongly suspected esophageal motility disorder
-Known or strongly suspected malignant stricture
-Non-anastomotic stricture
-Contra indication for HBOT:
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
oSevere epilepsy
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