Upper Gastrointestinal Disease,UlcersPhase 2/3NCT00273130
Stress Response Using Thin and Standard Size Endoscopy.
A Phase 2/3 study testing transnasal endoscopy and transoral thin endoscopy in people with Upper Gastrointestinal Disease,Ulcers, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups. 1. transnasal gastroscopy with thin endoscope 2. transoral with thin endoscope 3. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Disease,Ulcers
- What is being tested?
- transnasal endoscopy and transoral thin endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 1999to Aug 2002
- Phase
- Phase 2/3
- 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, age over 18, danish speaking,
Who cannot join
- use of beta blocking or any other heart rate modulating drug, antithyroid drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Evaluation of Neuroendocrine Stress Response During Upper Gastrointestinal Endoscopy With Standard or Ultrathin Endoscope.
Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups.
- transnasal gastroscopy with thin endoscope
- transoral with thin endoscope
- standard size trans-oral endoscopy Stress response parameters (epinephrine, nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were monitored.
Read the detailed description
A substantial number of descriptive studies and clinical trials have made it evident that upper gastrointestinal endoscopy elicits cardiovascular and respiratory changes. Recent publications have indicated less marked cardiovascular changes when using thinner endoscopes or transnasal endoscopy .Hormonal stress response during upper gastrointestinal endoscopy has also been described, but never related to the different methods of upper gastrointestinal endoscopy. Furthermore the patient tolerance is markedly improved compared to the standard transoral route.
The aim of the present randomised study was to evaluate the ECG-, blood pressure- and pulse rate changes and the endocrine stress response (norepinephrine, epinephrine and cortisol) elicited by upper gastrointestinal endoscopy using a thin endoscope either transnasally or orally or a standard endoscope orally.
Method and material Sixty patients were included consecutively after written and informed consent and were all over 18 years. Patients receiving digitalis, ß-blocking agents or calcium antagonists were excluded, as well as patients receiving drugs for thyroid dysfunction or patients receiving steroids. Patients with known disease or trauma of the nasal cavity were not included.
Only intended diagnostic upper gastrointestinal endoscopies were included. The patients received standard medication during the endoscopy if required.
Immediately prior to the endoscopy each of the 60 patients chose an envelope with the allocation to one of three groups A) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced transnasally (T group), B) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced orally (O group) or C) Endoscopy with a standard gastroscope (6 mm Olympus GIF XV10) (S group). All patients received the same amount of a local anesthetic spray (Lidocaine 10 mg/dose, ASTRA Zeneca) (twice in each nostril and twice in the oropharynx, given by one of two particular persons to ensure application of comparable doses of local anesthetic).
- Conditions
- Upper Gastrointestinal Disease,Ulcers
- Being tested
- transnasal endoscopy, transoral thin endoscopy
- Keywords
- transnasal gastroscopy, stress response, ischaemia
- Medical subject headings
- Gastrointestinal Diseases, Ulcer, Fractures, Stress, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transnasal endoscopyProcedure or surgery
transoral thin endoscopyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
tachycardia, ischaemia, level of stress response
Secondary outcomes (1)
acceptability of transnasal endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startMar 1999
- Study completionAug 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal Disease,UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Merete Christensen, MD, Principal investigator, Dept of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273130
- Sponsor's protocol ID
- MC-01-KAT
- Other IDs
- KF01-245/97
- Status last verified
- Dec 2003
- First submitted
- 5 Jan 2006
- Last updated
- 13 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Evaluation of Neuroendocrine Stress Response During Upper Gastrointestinal Endoscopy With Standard or Ultrathin Endoscope.
- ClinicalTrials.gov ID
- NCT00273130
- Acronym / sponsor ID
- MC-01-KAT
- Conditions
- Upper Gastrointestinal Disease,Ulcers
- Keywords
- transnasal gastroscopy, stress response, ischaemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Study start
- Mar 1999
- Study completion
- Aug 2002
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sixty patients scheduled for upper diagnostic gastroscopy were randomised after written informed consent into three groups.
- transnasal gastroscopy with thin endoscope
- transoral with thin endoscope
- standard size trans-oral endoscopy Stress response parameters (epinephrine, nor-epinephrine and cortisol, heartrate variability data and pulse oximetry data were monitored.
Detailed description
A substantial number of descriptive studies and clinical trials have made it evident that upper gastrointestinal endoscopy elicits cardiovascular and respiratory changes. Recent publications have indicated less marked cardiovascular changes when using thinner endoscopes or transnasal endoscopy .Hormonal stress response during upper gastrointestinal endoscopy has also been described, but never related to the different methods of upper gastrointestinal endoscopy. Furthermore the patient tolerance is markedly improved compared to the standard transoral route.
The aim of the present randomised study was to evaluate the ECG-, blood pressure- and pulse rate changes and the endocrine stress response (norepinephrine, epinephrine and cortisol) elicited by upper gastrointestinal endoscopy using a thin endoscope either transnasally or orally or a standard endoscope orally.
Method and material Sixty patients were included consecutively after written and informed consent and were all over 18 years. Patients receiving digitalis, ß-blocking agents or calcium antagonists were excluded, as well as patients receiving drugs for thyroid dysfunction or patients receiving steroids. Patients with known disease or trauma of the nasal cavity were not included.
Only intended diagnostic upper gastrointestinal endoscopies were included. The patients received standard medication during the endoscopy if required.
Immediately prior to the endoscopy each of the 60 patients chose an envelope with the allocation to one of three groups A) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced transnasally (T group), B) Endoscopy with a thin endoscope (4.5 mm Olympus prototype fiberendoscope) introduced orally (O group) or C) Endoscopy with a standard gastroscope (6 mm Olympus GIF XV10) (S group). All patients received the same amount of a local anesthetic spray (Lidocaine 10 mg/dose, ASTRA Zeneca) (twice in each nostril and twice in the oropharynx, given by one of two particular persons to ensure application of comparable doses of local anesthetic).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnostic gastroscopy, age over 18, danish speaking,
Key exclusion criteria (1 listed)
- use of beta blocking or any other heart rate modulating drug, antithyroid drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transnasal endoscopy | Procedure or surgery | – |
| transoral thin endoscopy | Procedure or surgery | – |
Primary outcome
tachycardia, ischaemia, level of stress response
1 secondary outcome
acceptability of transnasal endoscopy
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merete Christensen, MD principal investigator
Dept of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing transnasal endoscopy and transoral thin endoscopy in people with Upper Gastrointestinal Disease,Ulcers, 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 13 Sep 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
tachycardia, ischaemia, level of stress response. It is what the study was designed to measure, not a finding.
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 13 Sep 2006.