Early Gastric Cancer or Gastric AdenomaNCT02037399
Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection
A study testing intravenous dexamethasone and intravenous normal saline in people with Early Gastric Cancer or Gastric Adenoma, run by Yonsei University at 1 site in South Korea.
Trial summary
Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Early Gastric Cancer or Gastric Adenoma
- What is being tested?
- intravenous dexamethasone and intravenous normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Feb 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
- 20 years of age or older
- pathologically diagnosed gastric adenoma or cancer that was eligible for ESD
- patients who gave written informed consent from patients or responsible family members.
Who cannot join
- patients who take pain killer within 48 hours or regularly at enrollment
- confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease
- multiple gastric lesions for ESD
- history of gastric surgery at enrollment
- severe underlying disease including infection, cardiopulmonary disease, and diabetes.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine
Seoul, 120-752
Hyuk Lee, MD, 82-2-2228-1996, leehyuk@yuhs.ac
About this study
Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.
- Conditions
- Early Gastric Cancer or Gastric Adenoma
- Being tested
- intravenous dexamethasone, intravenous normal saline
- Keywords
- Endoscopic submucosal dissection, early gastric cancer, pain relief, intravenous dexamethasone, present pain intensity
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intravenous dexamethasoneDrug
Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including dexamethasone was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.
At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.
intravenous normal salineDrug
Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous normal saline as placebo immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including placebo was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.
At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| intravenous dexamethasone | Experimental | To receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD Receives: Drug: intravenous dexamethasone |
| intravenous normal saline | Placebo comparator | To receive normal saline as placebo intravenous immediately after ESD Receives: Drug: intravenous normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
present pain intensity (PPI)
The primary outcomes of this study was present pain intensity (PPI) measured at 6 hours after ESD. The reason for adopting 6- hour PPI as primary endpoint was due to maximized pain at 6 hours after ESD in our pilot study.
Measured: at 6 hours after ESD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startJul 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Gastric Cancer or Gastric AdenomaStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037399
- Sponsor's protocol ID
- 4-2013-0577
- Status last verified
- Jan 2014
- First submitted
- 13 Jan 2014
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
PubMed 19092351Diakos EA, Gallos ID, El-Shunnar S, Clarke M, Kazi R, Mehanna H. Dexamethasone reduces pain, vomiting and overall complications following tonsillectomy in adults: a systematic review and meta-analysis of randomised controlled trials. Clin Otolaryngol. 2011 Dec;36(6):531-42. doi: 10.1111/j.1749-4486.2011.02373.x.
PubMed 21812940De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
PubMed 21799397Kiriyama S, Oda I, Nishimoto F, Mashimo Y, Ikehara H, Gotoda T. Pilot study to assess the safety of local lidocaine injections during endoscopic submucosal dissection for early gastric cancer. Gastric Cancer. 2009;12(3):142-7. doi: 10.1007/s10120-009-0514-y. Epub 2009 Nov 5.
PubMed 19890693
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial on Efficacy of Single Dose Perioperative Intravenous Dexamethasone for Pain Relief After Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT02037399
- Acronym / sponsor ID
- 4-2013-0577
- Conditions
- Early Gastric Cancer or Gastric Adenoma
- Keywords
- Endoscopic submucosal dissection, early gastric cancer, pain relief, intravenous dexamethasone, present pain intensity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 15 Jan 2014 (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.
Besides major ESD-related complications, minor adverse events after ESD are also commonly noticed. Pain is one of minor ESD-related complications. . The causes of pain associated with ESD or gastric polypectomy are thought to be associated with transmural burn or transmural air leak. How control localized pain for patients who suffered from pain after ESD is appearing as new medical interests. There are few studies about management strategy for pain after ESD. Glucocorticoids are used to reduce inflammation and tissue damage in various clinical settings including inflammatory disease, rheumatic disease, and so on. The efficacy of glucocorticoids for reducing pain after surgery has recently been investigated. Glucocorticoids are thought to locally inhibit collagen deposition and fibrosis and finally reduce scar-tissue formation. Especially systemic steroids are easy to achieve a continuous effect through stable serum concentrations. If pain was partially associated with acute inflammation, we assumed intravenous dexamethasone could be helpful to relieve pain after ESD based on previous studies. we aimed to assess the efficacy of single dose postoperative intravenous dexamethasone for pain relief after ESD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous dexamethasone | Experimental | Drug: intravenous dexamethasoneTo receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD |
| intravenous normal saline | Placebo comparator | Drug: intravenous normal salineTo receive normal saline as placebo intravenous immediately after ESD |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 years of age or older
- pathologically diagnosed gastric adenoma or cancer that was eligible for ESD
- patients who gave written informed consent from patients or responsible family members.
Key exclusion criteria (5 listed)
- patients who take pain killer within 48 hours or regularly at enrollment
- confirmed any other disease which can induce epigastric pain such as peptic ulcer disease and gastroesophageal reflux disease
- multiple gastric lesions for ESD
- history of gastric surgery at enrollment
- severe underlying disease including infection, cardiopulmonary disease, and diabetes.
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 |
|---|---|---|
| intravenous dexamethasonePatients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including dexamethasone was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study. At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days. | Drug | intravenous dexamethasone |
| intravenous normal salinePatients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous normal saline as placebo immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including placebo was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study. At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days. | Drug | intravenous normal saline |
Primary outcome
present pain intensity (PPI)
Time frame: at 6 hours after ESD
The primary outcomes of this study was present pain intensity (PPI) measured at 6 hours after ESD. The reason for adopting 6- hour PPI as primary endpoint was due to maximized pain at 6 hours after ESD in our pilot study.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2014.
- Background: PubMed 19092351Worni M, Schudel HH, Seifert E, Inglin R, Hagemann M, Vorburger SA, Candinas D. Randomized controlled trial on single dose steroid before thyroidectomy for benign disease to improve postoperative nausea, pain, and vocal function. Ann Surg. 2008 Dec;248(6):1060-6. doi: 10.1097/SLA.0b013e31818c709a.
- Background: PubMed 21812940Diakos EA, Gallos ID, El-Shunnar S, Clarke M, Kazi R, Mehanna H. Dexamethasone reduces pain, vomiting and overall complications following tonsillectomy in adults: a systematic review and meta-analysis of randomised controlled trials. Clin Otolaryngol. 2011 Dec;36(6):531-42. doi: 10.1111/j.1749-4486.2011.02373.x.
- Background: PubMed 21799397De Oliveira GS Jr, Almeida MD, Benzon HT, McCarthy RJ. Perioperative single dose systemic dexamethasone for postoperative pain: a meta-analysis of randomized controlled trials. Anesthesiology. 2011 Sep;115(3):575-88. doi: 10.1097/ALN.0b013e31822a24c2.
- Background: PubMed 19890693Kiriyama S, Oda I, Nishimoto F, Mashimo Y, Ikehara H, Gotoda T. Pilot study to assess the safety of local lidocaine injections during endoscopic submucosal dissection for early gastric cancer. Gastric Cancer. 2009;12(3):142-7. doi: 10.1007/s10120-009-0514-y. Epub 2009 Nov 5.
Related trials for Early Gastric Cancer or Gastric Adenoma
Recruiting
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Early Gastric Cancer or Gastric Adenoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intravenous dexamethasone and intravenous normal saline in people with Early Gastric Cancer or 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 15 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyuk Lee, MD (82-2-2228-1996, leehyuk@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
present pain intensity (PPI) (time frame: at 6 hours after ESD). 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 NCT02037399, which also lists 4 linked publications.
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 15 Jan 2014.