the primary aim of this study is to evaluate the safety (adverse events and complaints) of submandibular duct ligation right after intraductal ethanol infusion into the submandibular salivary gland (Ethanol two-duct ligation [E-2DL] in order to…
ID
Source
Brief title
Condition
- Other condition
- Chromosomal abnormalities, gene alterations and gene variants
- Congenital and peripartum neurological conditions
Synonym
Health condition
Speekseklieren
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to evaluate the safety (adverse events and
complaints) of the procedure which is defined by adverse events and
post-operative complaints (i.e. safety), and surgical time.
Secondary outcome
Secondary outcomes include the suitability for an out-patient procedure.
Background summary
drooling is associated with physical, psychosocial, and emotional distress.
Previous studies revealed that submandibular duct ligation (2-DL) is an
effective and safe treatment for drooling in neurodisabilities. However, a
quarter of patients recurred in the period between week 8 and 32 weeks after
2-DL. Alternative salivary pathways were proposed as leading reason for
recurrence and treatment failure of 2-DL. Recent literature illustrated that
intraductal ethanol infusion in the salivary gland is safe and effective for
the treatment of drooling.
Study objective
the primary aim of this study is to evaluate the safety (adverse events and
complaints) of submandibular duct ligation right after intraductal ethanol
infusion into the submandibular salivary gland (Ethanol two-duct ligation
[E-2DL] in order to improve treatment effect, and prevent recurrence and
alternative salivary pathways after 2-DL. The secondary aims of the study are
to evaluate effect, and to evaluate whether an out-patient setting is suitable
for the procedure.
Study design
Prospective pilot study
Intervention
submandibular duct ligation right after intraductal ethanol infusion into the
submandibular salivary gland.
Study burden and risks
We expect some additional swelling of the submandibular region. There is some
risk for extravasation which could incude additional post-operative zwelling.
To minimize swelling we will prescribe per-operative medication. To prevent
extravasation, we will control infusion under sialography.
The benefit of the addition of Ethanol to submandibular duct ligation is that
we expect better treatment effect.
Philips van der Leijdenlaan 14
Nijmegen 6500HB
NL
Philips van der Leijdenlaan 14
Nijmegen 6500HB
NL
Listed location countries
Age
Inclusion criteria
1. Moderate to severe drooling indicated by Drooling Frequency Score >= 3 or
Drooling 370 Severity Score >= 2. 371
2. Aged 10 years and older. 372
3. Cerebral palsy or any other non-progressive neurodevelopmental disability.
373
4. Contra-indications for a SMDR, or rejection towards a SMDR by patient or
caregivers* 374
5. Ability and willingness to follow the study protocol and attend the 8 and
32-weeks vis-375 its. 376
6. Written and informed consent from caregivers, and when appropriate, oral
consent 377 from the child.
Exclusion criteria
1. Medical history of salivary gland abnormalities like ductal stenosis,
strictures
2. Previous submandibular salivary gland surgery, or other contraindications
for surgery 385 or general anesthesia. 386
3. Recent (<6 months) glandular Botulinum Neurotoxin A (BoNT-A) injection 387
4. Simultaneous alternative treatment for drooling.
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 | EUCTR2021-004057-23-NL |
| CCMO | NL77138.091.21 |