Gastric NeoplasmNCT02254889
Pain After Endoscopic Submucosal Dissection
A study testing proton pump inhibitor in people with Gastric Neoplasm, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric neoplasms. Although ESD-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after ESD. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Neoplasm
- What is being tested?
- proton pump inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2011to Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing ESD for gastric neoplasms
Who cannot join
- (1) history of acid suppressive medication within 1 week prior to the procedure; (2) known gastrointestinal disorders, such as peptic ulcer disease, which might impact epigastric pain assessment; (3) current or regular use of pain medication; (4) history of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or psychological disorders
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric neoplasms. Although ESD-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after ESD. Therefore, in the present study, we investigated the incidence and clinicopathologic risk factors of pain after ESD.
Read the detailed description
A prospective randomized controlled study was conducted evaluating 156 patients with gastric neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014. All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) either before or after ESD.
- Conditions
- Gastric Neoplasm
- Being tested
- proton pump inhibitor
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proton pump inhibitorDrug
). In the pre-ESD therapeutic group, a standard intravenous dose of PPI was given 2 hours before ESD. In the post-ESD therapeutic group, patients also received intravenous PPI in standard doses, once in the evening after ESD.
| Study group | Role | What they receive |
|---|---|---|
| pre-ESD group | Active comparator | All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD. Receives: Drug: proton pump inhibitor |
| post-ESD group | Placebo comparator | All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD. Receives: Drug: proton pump inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
A 10-cm VAS was used to evaluate pain after ESD.
Measured: Pain was rated at 24 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 posted2 Oct 2014 (estimated)
- Study startApr 2011
- Primary completionDec 2014
- Study completionDec 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 Gastric NeoplasmStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Da Hyun Jung, Gangnam Severance Hospital
- Investigators
- Young Hoon Youn, MD, PhD, Study director, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254889
- Sponsor's protocol ID
- 3-2011-0007
- Status last verified
- Feb 2016
- First submitted
- 25 Sep 2014
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jung DH, Youn YH, Kim JH, Park H. Factors influencing development of pain after gastric endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2015 Dec;47(12):1119-23. doi: 10.1055/s-0034-1392537. Epub 2015 Jul 10.
PubMed 26165736
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain After Endoscopic Submucosal Dissection
- ClinicalTrials.gov ID
- NCT02254889
- Acronym / sponsor ID
- 3-2011-0007
- Conditions
- Gastric Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Oct 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.
Endoscopic submucosal dissection (ESD) is widely used for local treatment of gastric neoplasms. Although ESD-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after ESD. Therefore, in the present study, we investigated the incidence and clinicopathologic risk factors of pain after ESD.
Detailed description
A prospective randomized controlled study was conducted evaluating 156 patients with gastric neoplasms treated by ESD at Gangnam Severance Hospital between April 2011 and December 2014. All subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) either before or after ESD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pre-ESD group | Active comparator | Drug: proton pump inhibitorAll subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) before ESD. |
| post-ESD group | Placebo comparator | Drug: proton pump inhibitorAll subjects were randomly assigned to treatment with intravenous proton pump inhibitor (PPI) after ESD. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing ESD for gastric neoplasms
Key exclusion criteria (1 listed)
- (1) history of acid suppressive medication within 1 week prior to the procedure; (2) known gastrointestinal disorders, such as peptic ulcer disease, which might impact epigastric pain assessment; (3) current or regular use of pain medication; (4) history of upper gastrointestinal surgery; (5) multiple lesions requiring ESD; (6) perforation during ESD; and (7) significant cardiovascular, renal, hepatic, neurotic, or psychological disorders
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 |
|---|---|---|
| proton pump inhibitor). In the pre-ESD therapeutic group, a standard intravenous dose of PPI was given 2 hours before ESD. In the post-ESD therapeutic group, patients also received intravenous PPI in standard doses, once in the evening after ESD. | Drug | post-ESD group, pre-ESD group |
Primary outcome
A 10-cm VAS was used to evaluate pain after ESD.
Time frame: Pain was rated at 24 hours after ESD.
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 12 Feb 2016.
- Derived from this study: PubMed 26165736Jung DH, Youn YH, Kim JH, Park H. Factors influencing development of pain after gastric endoscopic submucosal dissection: a randomized controlled trial. Endoscopy. 2015 Dec;47(12):1119-23. doi: 10.1055/s-0034-1392537. Epub 2015 Jul 10.
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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.
Young Hoon Youn, MD, PhD study director
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proton pump inhibitor in people with Gastric Neoplasm, run by Gangnam Severance Hospital 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 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: finished, as of the sponsor's last update on 12 Feb 2016. 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?
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?
A 10-cm VAS was used to evaluate pain after ESD. (time frame: Pain was rated at 24 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 NCT02254889, 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 12 Feb 2016.