Gastric Adenoma and Early Gastric CancerNCT02245971
A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum
A study testing Partial precutting and Whole precutting in people with Gastric Adenoma and Early Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Adenoma and Early Gastric Cancer
- What is being tested?
- Partial precutting and Whole precutting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 Jul 2013to 12 Aug 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 19 years old
- Patients with gastric adenoma or early gastric cancer
Who cannot join
- Patients who has undergone subtotal gastrectomy
- Patients who has undergone gastrostomy
- Patients with local recurred gastric adenoma or early gastric cancer
Trial locations and contacts
1 site in 1 country.
About this study
Endoscopic submucosal dissection (ESD) is an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent position, irrigated water and blood may prevent visual field of ESD.
Generally, whole precutting around the lesion during the ESD is performed prior to dissection. However, it is expected that partial precutting method for the lesion located in the antrum of the lesser curvature may improve the visibility of ESD because it can help us the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time of ESD for the lesion located in the antrum of the lesser curvature according to the precutting methods (whole precutting vs. partial precutting).
- Conditions
- Gastric Adenoma and Early Gastric Cancer
- Being tested
- Partial precutting, Whole precutting
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partial precuttingProcedure or surgery
Partial precutting will be performed prior to dissection during the ESD.
Whole precuttingProcedure or surgery
Whole precutting will be performed prior to dissection during the ESD.
| Study group | Role | What they receive |
|---|---|---|
| Whole precutting group | Active comparator | Not described Receives: Procedure: Whole precutting |
| Partial precutting group | Active comparator | Not described Receives: Procedure: Partial precutting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure time
Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.
Measured: Within 5 mins after the procedure
Secondary outcomes (1)
En bloc resection rate
En bloc resection rate according to the precutting methods.
Measured: Within 7 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study start26 Jul 2013
- Primary completion12 Aug 2014
- Study completion12 Aug 2014
Why it stopped: The investigators decided to terminate the study early because there were no patient candidates available for registration in the center.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Adenoma and 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
- 0 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
- NCT02245971
- Sponsor's protocol ID
- 4-2014-0380
- Status last verified
- Jan 2019
- First submitted
- 15 Sep 2014
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Precutting Methods of Endoscopic Submucosal Dissection for Gastric Neoplasms Located at Lesser Curvature Side of Antrum
- ClinicalTrials.gov ID
- NCT02245971
- Acronym / sponsor ID
- 4-2014-0380
- Conditions
- Gastric Adenoma and Early Gastric Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The investigators decided to terminate the study early because there were no patient candidates available for registration in the center.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 26 Jul 2013 (actual)
- Primary completion
- 12 Aug 2014 (actual)
- Study completion
- 12 Aug 2014 (actual)
- First posted
- 22 Sep 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 an advanced technique that enables en bloc resection of superficial tumors in the gastrointestinal tract. ESD, however, is a time-consuming procedure that requires a high level of endoscopic skill to achieve a desirable oncologic outcome. Especially, ESD for the lesion which is located in the antrum of lesser curvature side is difficult. Because the antrum of lesser curvature side is dependent position, irrigated water and blood may prevent visual field of ESD.
Generally, whole precutting around the lesion during the ESD is performed prior to dissection. However, it is expected that partial precutting method for the lesion located in the antrum of the lesser curvature may improve the visibility of ESD because it can help us the flap of the lesion evaginated easily. Therefore, we aimed to evaluate the procedure time of ESD for the lesion located in the antrum of the lesser curvature according to the precutting methods (whole precutting vs. partial precutting).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole precutting group | Active comparator | Procedure: Whole precutting |
| Partial precutting group | Active comparator | Procedure: Partial precutting |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Over 19 years old
- Patients with gastric adenoma or early gastric cancer
Key exclusion criteria (3 listed)
- Patients who has undergone subtotal gastrectomy
- Patients who has undergone gastrostomy
- Patients with local recurred gastric adenoma or early gastric cancer
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 |
|---|---|---|
| Partial precuttingPartial precutting will be performed prior to dissection during the ESD. | Procedure or surgery | Partial precutting group |
| Whole precuttingWhole precutting will be performed prior to dissection during the ESD. | Procedure or surgery | Whole precutting group |
Primary outcome
Procedure time
Time frame: Within 5 mins after the procedure
Procedure time for the lesion located in the antrum of lesser curvature according to the precutting methods.
1 secondary outcome
En bloc resection rate
Time frame: Within 7 days after the procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2019.
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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 Partial precutting and Whole precutting in people with Gastric Adenoma and Early Gastric Cancer, 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 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: withdrawn, as of the sponsor's last update on 16 Jan 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Procedure time (time frame: Within 5 mins after the procedure). 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 16 Jan 2019.