HYPerbaric OXygen therapy for benign anastomotIC esophageal strictures: a pilot study

Phase 3

Completed

Conditions: anastomotic stenosis
benign esophageal stenosis
10018008

Registration Number: NL-OMON40612

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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

Exclusion Criteria

- Known or strongly suspected esophageal motility disorder
- Known or strongly suspected malignant stricture
- Non-anastomotic esophageal stricture
- Contra indication for HBOT:
- Untreated pneumothorax
- Restrictive treated pneumothorax (without thoraxdrain)
- Severe respiratory diseases (COPD or pulmonary emphysema)
- Active infection of the upper airways
- Recent surgery of the middle ear
- Recent thoracic surgery
- Uncontrolled high fever
- Epilepsy
- Treatment with pulmonary toxic medication (bleomycine, doxorubicin, adriamycin, amiodaron,
furadantine)
- Previous treatment with bleomycine with pulmonary toxic reaction
- Known pregnancy or premenopausal woman that are not surgically sterile or taking oral
contraceptives

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To assess the effect of HBOT mean dysphagia free period </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To assess the effect of HBOT on;<br /><br>- number of reinterventions for recurrent dysphagia<br /><br>-number of patients who are dysphagia free for 6 months<br /><br>- quality of life (QLQ-C30 + OES 18)</p><br>