Stomach NeoplasmsIMNCT01499576
Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia
A study testing Acetic acid chromoendoscopy in people with Stomach Neoplasms and Metaplasia, run by Konyang University Hospital at 1 site in South Korea.
Trial summary
The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. Read more about this study
- Who is it for?
- Ages 35 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Stomach Neoplasms, Metaplasia
- What is being tested?
- Acetic acid chromoendoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Apr 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person who undergo gastroduodenoscopy
- Person who visit Konyang University Hospital
Who cannot join
- Bleeding diathesis
- History of stomach neoplasms
- History of upper gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Gastroenterology and Hepatology; Konyang University Hospital
Daejeon, 302-718
About this study
Official title: Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy > 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.
- Conditions
- Stomach Neoplasms, Metaplasia
- Being tested
- Acetic acid chromoendoscopy
- Keywords
- Mass Screening, Endoscopy, Gastrointestinal, Stomach Neoplasms, Metaplasia, Diagnosis, Acetic acid, Chromoendoscopy
- Medical subject headings
- Stomach Neoplasms, Metaplasia, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetic acid chromoendoscopyProcedure or surgery
Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy
| Study group | Role | What they receive |
|---|---|---|
| Acetic acid spraying | Experimental | Not described Receives: Procedure: Acetic acid chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.
Measured: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
Secondary outcomes (2)
Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists
The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.
We calculate the Kappa index of agreement for the acetic acid chromoendoscopy.
Measured: One month after the completion of the study
Number of Participants With Adverse Events
Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.
Measured: up to 1week after the acetic acid chromoendoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startNov 2011
- Primary completionMar 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stomach NeoplasmsStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung Ho Song, MD, Konyang University Hospital
- Investigators
- Kyung Ho Song, M.D., Master, Principal investigator, Konyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499576
- Sponsor's protocol ID
- 11-62
- Acronym
- IM
- Status last verified
- Sep 2014
- First submitted
- 20 Dec 2011
- Last updated
- 26 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lambert R, Rey JF, Sankaranarayanan R. Magnification and chromoscopy with the acetic acid test. Endoscopy. 2003 May;35(5):437-45. doi: 10.1055/s-2003-38766. No abstract available.
PubMed 12701018Lee BE, Kim GH, Park DY, Kim DH, Jeon TY, Park SB, You HS, Ryu DY, Kim DU, Song GA. Acetic acid-indigo carmine chromoendoscopy for delineating early gastric cancers: its usefulness according to histological type. BMC Gastroenterol. 2010 Aug 23;10:97. doi: 10.1186/1471-230X-10-97.
PubMed 20731830Cassaro M, Rugge M, Gutierrez O, Leandro G, Graham DY, Genta RM. Topographic patterns of intestinal metaplasia and gastric cancer. Am J Gastroenterol. 2000 Jun;95(6):1431-8. doi: 10.1111/j.1572-0241.2000.02074.x.
PubMed 10894575Song KH, Hwang JA, Kim SM, Ko HS, Kang MK, Ryu KH, Koo HS, Lee TH, Huh KC, Choi YW, Kang YW. Acetic acid chromoendoscopy for determining the extent of gastric intestinal metaplasia. Gastrointest Endosc. 2017 Feb;85(2):349-356. doi: 10.1016/j.gie.2016.07.064. Epub 2016 Aug 8.
PubMed 27515128
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia
- ClinicalTrials.gov ID
- NCT01499576
- Acronym / sponsor ID
- IM / 11-62
- Conditions
- Stomach Neoplasms, Metaplasia
- Keywords
- Mass Screening, Endoscopy, Gastrointestinal, Stomach Neoplasms, Metaplasia, Diagnosis, Acetic acid, Chromoendoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Konyang University HospitalUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Posted 26 Sep 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy > 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acetic acid spraying | Experimental | Procedure: Acetic acid chromoendoscopy |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Person who undergo gastroduodenoscopy
- Person who visit Konyang University Hospital
Key exclusion criteria (3 listed)
- Bleeding diathesis
- History of stomach neoplasms
- History of upper gastrointestinal surgery
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 |
|---|---|---|
| Acetic acid chromoendoscopyAcetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy | Procedure or surgery | Acetic acid spraying |
Primary outcome
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy
Time frame: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)
Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.
2 secondary outcomes
Agreement of Acetic Acid Chromoendoscopic Reading Between the Two Endoscopists
Time frame: One month after the completion of the study
Number of Participants With Adverse Events
Time frame: up to 1week after the acetic acid chromoendoscopy
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12701018Lambert R, Rey JF, Sankaranarayanan R. Magnification and chromoscopy with the acetic acid test. Endoscopy. 2003 May;35(5):437-45. doi: 10.1055/s-2003-38766. No abstract available.
- Background: PubMed 20731830Lee BE, Kim GH, Park DY, Kim DH, Jeon TY, Park SB, You HS, Ryu DY, Kim DU, Song GA. Acetic acid-indigo carmine chromoendoscopy for delineating early gastric cancers: its usefulness according to histological type. BMC Gastroenterol. 2010 Aug 23;10:97. doi: 10.1186/1471-230X-10-97.
- Background: PubMed 10894575Cassaro M, Rugge M, Gutierrez O, Leandro G, Graham DY, Genta RM. Topographic patterns of intestinal metaplasia and gastric cancer. Am J Gastroenterol. 2000 Jun;95(6):1431-8. doi: 10.1111/j.1572-0241.2000.02074.x.
- Derived from this study: PubMed 27515128Song KH, Hwang JA, Kim SM, Ko HS, Kang MK, Ryu KH, Koo HS, Lee TH, Huh KC, Choi YW, Kang YW. Acetic acid chromoendoscopy for determining the extent of gastric intestinal metaplasia. Gastrointest Endosc. 2017 Feb;85(2):349-356. doi: 10.1016/j.gie.2016.07.064. Epub 2016 Aug 8.
- Konyang University Hospital, Web pageLink provided by the sponsor.
Related trials for Stomach Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Not yet recruitingPhase 1
GK01 Cell Therapy in Gastric Cancer With Peritoneal Metastasis
Gastric Cancer (GC)
RecruitingPhase 3
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
Gastric, Esophagogastric Junction
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Kyung Ho Song, M.D., Master principal investigator
Konyang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetic acid chromoendoscopy in people with Stomach Neoplasms and Metaplasia, run by Konyang University 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 2 inclusion and 3 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 26 Sep 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?
Yes. Results are posted in the registry (first posted 26 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Agreement Between Acetic Acid Chromoendoscopy and Endoscopic Biopsy (time frame: 3 months after the completion of the study (a pathologist reviewed all the biopsy slide)). 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 NCT01499576, 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 26 Sep 2014.