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Upper Gastrointestinal Disease, Duodenal or Gastric Ulcer.NCT00273117

Transnasal and Oral Gastroscopy.

An observational study of Upper Gastrointestinal Disease, Duodenal or Gastric Ulcer., run by Hvidovre University Hospital at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Two groups of patients were randomised into two groups of either transnasal gastroscopy or conventional type gastroscopy (n=98). The aim of the study was to evaluate the cardiorespiratory effects and sideeffects of the two methods, and to evaluate the technical features of the transnasal endoscope. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
transnasal gastroscopy
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteDenmark
Study dates
Feb 2002to Aug 2003
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnostic gastroscopy, written informed consent

Who cannot join

  • history of broken nose or disease of the nasal cavity, no Danish language, age under 18

Trial locations and contacts

1 site in 1 country.

Denmark1 site
  • Dept of Surgery University Hospital of Glostrup

    Glostrup Municipality, Glostrup, 2600

Other trials in Denmark

About this study

Official title: Transnasal and Conventional Oral Diagnostic Gastroscopy. A Prospective Randomised Study.

Two groups of patients were randomised into two groups of either transnasal gastroscopy or conventional type gastroscopy (n=98). The aim of the study was to evaluate the cardiorespiratory effects and sideeffects of the two methods, and to evaluate the technical features of the transnasal endoscope.

Read the detailed description

Introduction Esophagogastroduodenoscopy is the gold standard investigation for upper gastrointestinal disorders. To make the procedure safer and more comfortable, thinner endoscopes for conventional oral or for transnasal intubation have been designed. Several trials have been conducted suggesting greater patient tolerance with the thinner scope. At the same time scope features have improved and are increasingly compatible with the standard endoscope. This prospective, randomised study was conducted to evaluate the cardiopulmonary effects, the patient tolerance, and endoscopist evaluation comparing thin transnasal with conventional transoral endoscopy.

Patients and Methods Outpatients referred to diagnostic, upper gastrointestinal endoscopy were included consecutively after written informed consent. Inclusion criteria were age over 18 years, Danish-language, no history of disease in the nasal cavity and intended diagnostic endoscopy. Ninety-eight patients were included and randomised to either conventional oral gastroscopy (OG) or transnasal gastroscopy (TG).The patients were randomized by consecutively numbered envelopes.

The patients answered a questionnaire clarifying their previous experience of gastroscopy, and if relevant, the discomfort of previous examination and their anxiety for the actual examination on a visual analogue scale (VAS scale). A post endoscopy questionnaire evaluated discomfort during the examination in general, during introduction of the endoscope and for the rest of the examination (VAS scale). The following parameters were assessed by answering yes or no; gagging, choking, pain from the nose, throat and the stomach. The patients stated whether the degree of discomfort had been greater, lesser or as expected compared to previous endoscopy and whether they in a future gastroscopy would prefer sedation, and finally they stated their preference for a future procedure (OG/TG).

TG were carried out using Olympus Videoscope GIF-N230 (Olympus Optical Ltd., Tokyo, Japan) with an outer diameter of 6 mm and working length of 925 mm (first 15 patients); and later Olympus Videoscope GIF-XP160 (33 patients) with an outer diameter of 5.9 mm, and a working length of 1030 mm. OG were carried out using Olympus Videoscope GIF-Q160 with an outer diameter of 9.5 mm and a working length of 1030 mm.

All patients received topical anaesthesia; before TG xylocain gel were inhaled into each nostril and before OG xylocain spray (10 mg/dose), 4 doses were spayed into the pharyngeal cavity. Intravenous sedation using midazolam were used only if specifically requested by the patient. The patients were positioned in the left lateral recumbent position during the procedures. Endoscopies were performed by experienced endoscopists.

Arterial oxygen saturation (SpO2 ) and heart rate (HR) were measured by a pulse oximeter (Nellcor Symphony N-3000, Nellcor Puritan Bennet Inc., Pleasanton, CA) twice with an interval of one minute before the procedure; twice during the procedure (one and three minutes after intubation) and finally one and two minutes after extubation. The minimum SpO2 and maximum HR were noted as was the duration of the procedure. Biopsies were taken when indicated, and the qualities of the biopsies were assessed. Adverse effects during the endoscopies were noted; e.g. epistaxis.

After the endoscopy, the endoscopists answered a questionnaire evaluating the following parameters using a VAS score: intubation, ability to aspirate gastric contents, visualization of the esophagus, the stomach, the bulb and the second part of duodenum. The presence of chromatic aberrations (after flushing and aspiration), were also assessed. It was noted whether the length of the scope was sufficient, and also in case of TG, the presence of uni- or bi-lateral stenosis of the nasal cavity and looping in esophagus. If TG could not be carried out, the reasons were noted.

Finally, the endoscopists assessed their total subjective evaluation of the endoscopy on a one-to-six scale (one: unacceptable, six: perfect).

Being tested
transnasal gastroscopy
Keywords
transnasal gastroscopy, tachycardia, hypoxemia
Medical subject headings
Gastrointestinal Diseases, Stomach Ulcer, Tachycardia, Hypoxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • transnasal gastroscopyProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2006 (estimated)
  2. Study startFeb 2002
  3. Study completionAug 2003

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Natural history
Time perspective
Prospective
Enrolment
100 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00273117
Sponsor's protocol ID
MC-01-GLO
Other IDs
Ethics commitee nr KA00066m
Status last verified
Jan 2006
First submitted
5 Jan 2006
Last updated
9 Jan 2006
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Upper Gastrointestinal Disease, Duodenal or Gastric Ulcer., run by Hvidovre University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2006.

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