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Hyperbaric oxygen therapy for benign anastomotic esophageal strictures: a pilot study


- candidate number15831
- NTR NumberNTR4308
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-dec-2013
- Secondary IDs13-095 Ethical committee Utrecht
- Public TitleHyperbaric oxygen therapy for benign anastomotic esophageal strictures: a pilot study
- Scientific TitleHyperbaric oxygen therapy for benign anastomotic esophageal strictures: a pilot study
- ACRONYMHypoxic-study
- hypothesishyperbaric oxygen therapy can reverse tissue hypoxia in esophageal anastomotic strictures. Furthermore, due to this increased tissue oxygenation there will be less stricture reformation after dilation of the stricture
- Healt Condition(s) or Problem(s) studiedBenign anastomotic stricture, Oesophagectomy
- 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-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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 27-nov-2013
- planned closingdate27-mei-2015
- Target number of participants10
- InterventionsHyperbaric 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 pressure can be controlled (hyperbaric chamber).
-HBO treatment schedule: 5 days/week, 30 sessions (total 6 weeks).
- Primary outcomeTo assess the effect of hyperbaric oxygen therapy on the mucosal capillary hemoglobin oxygen saturation levels in the esophagus and the gastric tube
- Secondary outcome- To assess the effect of hyperbaric oxygen therapy on:
- dysphagia symptoms
- quality of life (QLQ-C30 + OES 18)
- TimepointsScreening at Institute for hyperbaric medicine

Baseline:
1. Baseline characteristics
2. Ogilvie score
3. Quality of life (QLQ-C30 + OES 18)
4. Visible light spectroscopy in esophagus and stomach
5. Savary dilation


Hyperbaric oxygen therapy, start <1 week after dilation:
1. 30 sessions of 110 minutes at 2.5 atmospheres

Telephone follow-up two weeks after savery:
1. Ogilvie score
2. Complications


Telephone follow-up four weeks after Savery dilation:
1. Ogilvie score
2. Complications


Two months after Savary dilation:
1. Visible light spectroscopy
2. Quality of life (QLQ-C30 + OES 18)
3. Ogilvie score
4. Complications


Telephone follow-up three months after Savery dilation:
1. Ogilvie score
2. Complications


Telephone follow-up four months after Savery dilation:
1. Ogilvie score
2. Complications


Telephone follow-up five months after Savery dilation:
1. Ogilvie score
2. Complications


Telephone follow-up six months after Savery dilation:
1. Ogilvie score
2. Complications
3. Quality of life (QLQ-C30 + OES 18)
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD W.F.W. Kappelle
- CONTACT for SCIENTIFIC QUERIESMD W.F.W. Kappelle
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryThe 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. The overall objective of this pilot study is to evaluate the effect of HBOT on recurrent and refractory esophageal anastomotic strictures.
- Main changes (audit trail)
- RECORD5-dec-2013 - 2-feb-2014


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