Condition category
Digestive System
Date applied
23/07/2014
Date assigned
12/08/2014
Last edited
29/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Beatriz Arenaz Bua

ORCID ID

Contact details

ÖNH kliniken
Skanes Universitetssjukhuset
Jan Waldenström gata 18
Malmö
205 02
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Treatment of cricopharyngeal dysfunction: a comparative pilot study

Acronym

Study hypothesis

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

Lund University Ethical Committee, 22/05/2007, ref. Dnr 179/2007

Study design

Prospective randomized pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

1. Medical instability
2. Cervical spine with osteophytes
3. Untreated gastroesophageal reflux

Recruitment start date

01/01/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Sweden

Trial participating centre

Skanes Universitetssjukhuset
Malmö
205 02
Sweden

Sponsor information

Organisation

Skåne University Hospital (Region Skåne) (Sweden)

Sponsor details

ÖNH kliniken
Skanes Universitetssjukhuset
Jan Waldenström gata 18
Malmö
20502
Sweden

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Skåne University Hospital (Region Skåne) (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Acta Oto-laryngologica Foundation, Stockholm (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Agnes Ljungren's Found, Lund (Sweden)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26159167

Publication citations

Additional files

Editorial Notes

29/03/2016: Publication reference added.