Early Gastric CancerNCT01806753
Performance of Endoscopic Submucosal Dissection According to the Sedation Method
A study testing Continuous propofol infusion with opioid administration in people with Early Gastric Cancer and Gastric Adenoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer, Gastric Adenoma
- What is being tested?
- Continuous propofol infusion with opioid administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2013to Jan 2014
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age, between 20 and 80
- Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection
- ECOG performance status 0 or 1
- American Society of Anesthesiologist Physical Status 1, 2, or 3
Who cannot join
- Previous subtotal gastrectomy
- Previous gastrostomy
- Repeated endoscopic submucosal dissection
- Three or more synchronous lesions
- Allergy to midazolam, propofol, fentanyl, or remifentanil
- Pregnancy or breast milk feeding
Show all 12Show fewer
- Active infection
- Significant cardiopulmonary disease
- Active hepatitis or severe hepatic dysfunction
- Severe renal dysfunction
- Severe bone marrow dysfunction
- Severe neurologic or psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Being tested
- Intermittent midazolam/propofol injection controlled by endoscopist, Continuous propofol infusion with opioid administration
- Keywords
- Endoscopic submucosal dissection, Sedation, Propofol, Midazolam
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent midazolam/propofol injection controlled by endoscopistProcedure or surgery
In this arm1, sedation during endoscopic submucosal dissection is controlled by endoscopists.
First, pethidine 50 mg with midazolam 0.05 mg/kg are injected in a bolus fashion.
When the patient seems to be discomfort or the patient's movements were observed, endoscopists should check the Modified Observer Assessment of Alertness/Sedation (MOAAS).
If MOAAS is 5 or 6, propofol 0.25 mg/kg will be injected. Otherwise, pethidine 12.5 mg will be injected.
Continuous propofol infusion with opioid administrationProcedure or surgery
In this arm2, sedation during endoscopic submucosal dissection is controlled by anesthesiologists.
First, remifentanil 0.5 ug/kg with propofol 0.5 mg/kg are injected in a bolus fashion.
Then, remifentanil 0.08 ug/kg/min and propofol 2 mg/kg/h are infused continuously.
When the patient seems to be discomfort or the patient's movements were observed, anesthesiologists should check the MOAAS.
If MOAAS is 5 or 6, infusion rate of propofol will be increased by 0.5 mg/kg/h. Otherwise, infusion rate of remifentanil will be increased by 0.02 ug/kg/min.
| Study group | Role | What they receive |
|---|---|---|
| midazolam/propofol injection | Experimental | Intermittent midazolam/propofol injection controlled by endoscopist Receives: Procedure: Intermittent midazolam/propofol injection controlled by endoscopist |
| propofol infusion | Active comparator | Continuous propofol infusion with opioid administration Receives: Procedure: Continuous propofol infusion with opioid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of endoscopists
Measured: Within 10 minutes from the end of the endoscopic submucosal dissection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806753
- Sponsor's protocol ID
- 4-2012-0661
- Status last verified
- Jan 2014
- First submitted
- 5 Mar 2013
- Last updated
- 30 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park CH, Shin S, Lee SK, Lee H, Lee YC, Park JC, Yoo YC. Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial. PLoS One. 2015 Mar 24;10(3):e0120529. doi: 10.1371/journal.pone.0120529. eCollection 2015.
PubMed 25803441
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Endoscopic Submucosal Dissection According to the Sedation Method
- ClinicalTrials.gov ID
- NCT01806753
- Acronym / sponsor ID
- 4-2012-0661
- Conditions
- Early Gastric Cancer, Gastric Adenoma
- Keywords
- Endoscopic submucosal dissection, Sedation, Propofol, Midazolam
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 7 Mar 2013 (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.
Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| midazolam/propofol injection | Experimental | Procedure: Intermittent midazolam/propofol injection controlled by endoscopistIntermittent midazolam/propofol injection controlled by endoscopist |
| propofol infusion | Active comparator | Procedure: Continuous propofol infusion with opioid administrationContinuous propofol infusion with opioid administration |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age, between 20 and 80
- Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection
- ECOG performance status 0 or 1
- American Society of Anesthesiologist Physical Status 1, 2, or 3
Key exclusion criteria (12 listed)
- Previous subtotal gastrectomy
- Previous gastrostomy
- Repeated endoscopic submucosal dissection
- Three or more synchronous lesions
- Allergy to midazolam, propofol, fentanyl, or remifentanil
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 |
|---|---|---|
| Intermittent midazolam/propofol injection controlled by endoscopistIn this arm1, sedation during endoscopic submucosal dissection is controlled by endoscopists. First, pethidine 50 mg with midazolam 0.05 mg/kg are injected in a bolus fashion. When the patient seems to be discomfort or the patient's movements were observed, endoscopists should check the Modified Observer Assessment of Alertness/Sedation (MOAAS). If MOAAS is 5 or 6, propofol 0.25 mg/kg will be injected. Otherwise, pethidine 12.5 mg will be injected. | Procedure or surgery | midazolam/propofol injection |
| Continuous propofol infusion with opioid administrationIn this arm2, sedation during endoscopic submucosal dissection is controlled by anesthesiologists. First, remifentanil 0.5 ug/kg with propofol 0.5 mg/kg are injected in a bolus fashion. Then, remifentanil 0.08 ug/kg/min and propofol 2 mg/kg/h are infused continuously. When the patient seems to be discomfort or the patient's movements were observed, anesthesiologists should check the MOAAS. If MOAAS is 5 or 6, infusion rate of propofol will be increased by 0.5 mg/kg/h. Otherwise, infusion rate of remifentanil will be increased by 0.02 ug/kg/min. | Procedure or surgery | propofol infusion |
Primary outcome
Satisfaction of endoscopists
Time frame: Within 10 minutes from the end of the endoscopic submucosal dissection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2014.
- Derived from this study: PubMed 25803441Park CH, Shin S, Lee SK, Lee H, Lee YC, Park JC, Yoo YC. Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial. PLoS One. 2015 Mar 24;10(3):e0120529. doi: 10.1371/journal.pone.0120529. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous propofol infusion with opioid administration in people with Early Gastric Cancer and Gastric Adenoma, run by Yonsei University at 1 site in South Korea.
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 4 inclusion and 12 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: finished, as of the sponsor's last update on 30 Jan 2014. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Satisfaction of endoscopists (time frame: Within 10 minutes from the end of the endoscopic submucosal dissection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01806753, which also lists 1 linked publication.
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 30 Jan 2014.