Randomized Controlled Trial of Fetoscopic Endoluminal Tracheal Occlusion With a Balloon Versus Expectant Management During Pregnancy in Fetuses With Left Sided Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia.
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | August 2010 |
| End Date: | December 2019 |
| Contact: | Jan A Deprest, MD PhD |
| Email: | Jan.Deprest@uzleuven.be |
| Phone: | +3216344215 |
Randomized Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) Versus Expectant Management During Pregnancy in Fetuses With Left Sided and Isolated Congenital Diaphragmatic Hernia and Moderate Pulmonary Hypoplasia.
Isolated Congenital Diaphragmatic Hernia (CDH) can be diagnosed in the prenatal period, and
remains associated with an 30 % chance of perinatal death and morbidity mainly because of
pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a
high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases.
The risk for these can be predicted prenatally by the ultrasonographic measurement of the
observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of
pulmonary hypoplasia. Also position of the liver is predictive of outcome.
The proposing consortium has developed a prenatal therapeutic approach, which consists of
percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the
balloon . Both procedures are performed percutaneously, there is now experience with more
than 150 cases and it has been shown to be safe for the mother. We have witnessed an
improvement of survival in fetuses with a predicted chance of survival of less than 30%
(referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation)
to 55% on average. Also there is an apparent reduction in morbidity with the rate of
bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than
40% in the same severity group .
Further we have shown that results of FETO are predicted by LHR measurement prior to the
procedure , so that better results can be expected in fetuses with larger lung size .
Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%,
irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation
of the liver). When managed expectantly the estimated rate of postnatal survival is 60% or
lower and the rate of broncho-pulmonary dysplasia in survivors is 33% or higher.
This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant
management during pregnancy, both followed by standardized postnatal management, decreases
the occurrence of bronchopulmonary dysplasia or increases survival. The balloon will be
placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.
remains associated with an 30 % chance of perinatal death and morbidity mainly because of
pulmonary hypoplasia and pulmonary hypertension. In addition, in the survivors there is a
high rate of morbidity with evidence of bronchopulmonary dysplasia in more than 70% of cases.
The risk for these can be predicted prenatally by the ultrasonographic measurement of the
observed/expected lung area to head circumference ratio (O/E LHR) which is a measure of
pulmonary hypoplasia. Also position of the liver is predictive of outcome.
The proposing consortium has developed a prenatal therapeutic approach, which consists of
percutaneous fetoscopic endoluminal tracheal occlusion (FETO) with subsequent removal of the
balloon . Both procedures are performed percutaneously, there is now experience with more
than 150 cases and it has been shown to be safe for the mother. We have witnessed an
improvement of survival in fetuses with a predicted chance of survival of less than 30%
(referred to as fetuses with severe pulmonary hypoplasia; O/E LHR <25% and liver herniation)
to 55% on average. Also there is an apparent reduction in morbidity with the rate of
bronchopulmonary dysplasia decreasing from the estimated rate of more than 70% to less than
40% in the same severity group .
Further we have shown that results of FETO are predicted by LHR measurement prior to the
procedure , so that better results can be expected in fetuses with larger lung size .
Therefore we now aim to offer FETO to fetuses with moderate CDH (=O/E LHR 25-34.9%,
irrespective of the liver position as well as O/E LHR 35-44.9% with intrathoracic herniation
of the liver). When managed expectantly the estimated rate of postnatal survival is 60% or
lower and the rate of broncho-pulmonary dysplasia in survivors is 33% or higher.
This trial will test whether temporary fetoscopic tracheal occlusion rather than expectant
management during pregnancy, both followed by standardized postnatal management, decreases
the occurrence of bronchopulmonary dysplasia or increases survival. The balloon will be
placed between 30 and 31+6 weeks, and will be removed between 34 and 34+6 weeks.
Inclusion Criteria:
- Patients aged 18 years or more, who are able to consent
- Singleton pregnancy
- Anatomically and chromosomally normal fetus
- Left sided diaphragmatic hernia
- Gestation at randomization prior to 31 wks plus 5 d (so that occlusion is done at the
latest on 31 wks plus 6 d)
- Estimated to have moderate pulmonary hypoplasia, defined prenatally as:
- O/E LHR 25-34.9% (included; irrespective of the position of the liver)
- O/E LHR 35-44.9% (included) with intrathoracic liver herniation as determined by
ultrasound or MRI
- Acceptance of randomization and the consequences for the further management during
pregnancy and thereafter.
- The patients must undertake the responsibility for either remaining close to, or at
the FETO center, or being able to travel swiftly and within acceptable time interval
to the FETO center until the balloon is removed.
- Intended postnatal treatment center must subscribe to suggested guidelines for
"standardized postnatal treatment".
- Provide written consent to participate in this RCT
Exclusion Criteria:
- Maternal contraindication to fetoscopic surgery or severe medical condition in
pregnancy that make fetal intervention risk full
- Technical limitations precluding fetoscopic surgery, such as severe maternal obesity,
uterine fibroids or potentially others, not anticipated at the time of writing this
protocol.
- Preterm labour, cervix shortened (<15 mm at randomization) or uterine anomaly strongly
predisposing to preterm labour, placenta previa
- Patient age less than 18 years
- Psychosocial ineligibility, precluding consent
- Diaphragmatic hernia: right-sided or bilateral, major anomalies, isolated left-sided
outside the O/E LHR limits for the inclusion criteria
- Patient refusing randomization or to comply with return to FETO center during the time
period the airways are occluded or for elective removal of the balloon
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