Comparative study on treatment methods in cricopharyngeal dysfunction
| ISRCTN | ISRCTN84905610 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84905610 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/07/2014
- Registration date
- 12/08/2014
- Last edited
- 29/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Cricopharyngeal dysfunction is a narrowing between the end of the pharynx (throat) and the oesophagus (food pipe) caused by the sphincter (a ring of muscle) not relaxing or a lack of coordination between the pharynx and oesophagus. Difficulty swallowing (dysphagia) is a typical symptom. In this study, we compared the effect of two different treatments: balloon dilatation and laser myotomy.
Who can participate?
Patients with swallowing problems caused by cricopharyngeal dysfunction.
What does the study involve?
Patients answered a questionnaire about their swallowing difficulties and they underwent an X-ray called videomanometry three times: before treatment, and 1 and 6 months after treatment. It took about 10 minutes. A local anaesthetic was applied in the one of the nostrils. A soft and narrow tube was introduced through the nose into the esophagus. After the cause of their swallowing difficulties was found, patients were randomly allocated to one of two treatments. The two treatment methods were opening with a balloon or laser surgery in the affected area.
What are the possible benefits and risks of participating?
The benefit for those who took part in this study is that they received consultation and treatment of their swallowing difficulties. The result of the study will help to improve the treatment of all other patients with swallowing disorders. The risk was suffering an allergic reaction to local anesthetics, although this type of allergy is very rare. The radiation dose given at the X-ray examination was not higher than it would otherwise have been exposed to as part of the routine examination of swallowing problems.
Where is the study run from?
The study ran in the Skåne University Hospital (Sweden).
When is the study starting and how long is it expected to run for?
Recruitment started in 2008. Participants have been enrolled on the study for a period of 6 months. The study ran until 2012.
Who is funding the study?
1. Skåne University Hospital (Region Skåne) (Sweden)
2. Acta Oto-laryngologica Foundation, Stockholm (Sweden)
3. Agnes Ljungren´s Found, Lund (Sweden)
Who is the main contact?
Dr Beatriz Arenaz Búa, MD
Phone: +46 40 332324; +46 762230949
E-mail: barenazb@yahoo.com
Contact information
Scientific
ÖNH kliniken
Skanes Universitetssjukhuset
Jan Waldenström gata 18
Malmö
205 02
Sweden
Study information
| Study design | Prospective randomized pilot study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Treatment of cricopharyngeal dysfunction: a comparative pilot study |
| Study objectives | We aimed to compare treatments, at baseline and 1 and 6 months post-operative, using the Sydney Swallow Questionnaire (score should decrease when the patients feel better) and videomanometry (parameters should change i.e. sagittal diameter at UES should increase). |
| Ethics approval(s) | Lund University Ethical Committee, 22/05/2007, ref. Dnr 179/2007 |
| Health condition(s) or problem(s) studied | Dysphagia, cricopharyngeal dysfunction |
| Intervention | Participation meant that patients underwent an X-ray named videomanometry and answered a questionnaire about their swallowing difficulties before and 1 and 6 months after treatment. That procedure assessed the pharyngoesophageal function and anatomy. A local anaesthetic was applied in the one of the nostrils before a soft and narrow tube was introduced through the nose into the oesophagus. Treatment was decided by a process called randomisation, which is like a coin toss. Two treatment methods were available: dilation with a balloon or surgery with laser of the area between throat and oesophagus (named cricopharyngeal muscle). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Videomanometry, to assess pressure and dynamic anatomy during swallowing 2. Sydney Swallow Questionnaire, self-assessment tool, used to assign a score between 0 (no swallowing problems) and 1700 (maximum grade of swallowing problems) - completed before treatment and then 1 and 6 months after treatment |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2008 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Key inclusion criteria | 1. Patients with oropharyngeal dysphagia caused by cricopharyngeal dysfunction 2. Aged between 50-85 years 3. Willing to be assigned to any of the study intervention groups 4. Swallowing difficulty (dysphagia) for more than 3 months 5. Videomanometry showing cricopharyngeal dysfunction with reduction of UES diameter that exceeds 50%, high resting pressure or delayed/incomplete relaxation of UES 6. Should understand and speak Swedish |
| Key exclusion criteria | 1. Medical instability 2. Cervical spine with osteophytes 3. Untreated gastroesophageal reflux |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Sweden
Study participating centre
205 02
Sweden
Sponsor information
Hospital/treatment centre
ÖNH kliniken
Skanes Universitetssjukhuset
Jan Waldenström gata 18
Malmö
20502
Sweden
"ROR" |
https://ror.org/02z31g829 |
|---|
Funders
Funder type
Other
No information available
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 10/07/2015 | Yes | No |
Editorial Notes
29/03/2016: Publication reference added.
