The overall objective of this pilot study is to evaluate the effect of HBOT on recurrent and refractory esophageal anastomotic strictures.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To assess the effect of HBOT mean dysphagia free period
Secondary outcome
- To assess the effect of HBOT on;
- number of reinterventions for recurrent dysphagia
-number of patients who are dysphagia free for 6 months
- quality of life (QLQ-C30 + OES 18)
Background summary
The ideal treatment modality for recurrent and refractory esophageal
anastomotic strictures has not yet been established. Since ischemia is found to
be an important risk factor for the development of strictures, reversing tissue
hypoxia might have a role in the treatment of recurrent and refractory
anastomotic strictures. Tissue hypoxia can be reversed by using hyperbaric
oxygen therapy (HBOT). Studies on the effect of HBOT on anastomotic strictures
in humans have not yet been performed. However, two studies in rats with
colonic anastomoses showed that ischemia impairs anastomotic healing and that
adequate tissue oxygenation is the main factor for wound and anastomotic
healing.
Study objective
The overall objective of this pilot study is to evaluate the effect of HBOT on
recurrent and refractory esophageal anastomotic strictures.
Study design
Prospective, single-arm, pilot study in 10 patients
Intervention
Hyperbaric Oxygen Therapy
Study burden and risks
The burden of participation in this study is significant and comprises HBOT for
6 weeks, 5/days a week for 110 minutes per session. However, the included
patients are those patients already suffering from dysphagia complaints for a
long time and are treated with Savary dilations for a long period on short,
regular intervals. The potential benefit of participation in this study is an
increased dysphagia free interval and hopefully no recurrence of dysphagia at
all. In case of an increased dysphagia free interval, the interval between
Savary dilations will increase and less dilations sessions will be necessary.
The risk of participation is low, as the potential side effects of HBOT are
mild and reversible.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-000603-16-NL |
| CCMO | NL43628.041.13 |