Endoscopic Submucosal DissectionNCT05265221
Learning Curve for Gastric Endoscopic Submucosal Dissection
An observational study of Endoscopic Submucosal Dissection and Gastric Neoplasm, run by Soonchunhyang University Hospital at 1 site in South Korea.
Trial summary
Endoscopic submucosal dissection (ESD) for early gastric cancer is a widely accepted treatment option of expanded indication worldwide. ESD is relatively difficult compared with endoscopic mucosal resection, thus, proper training is essential for the safe performance of the procedure. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Endoscopic Submucosal Dissection, Gastric Neoplasm
- What is being tested?
- Endoscopic submucosal dissection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 356 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2022to 31 May 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who underwent endoscopic dissection due to gastric neoplasms
Who may be able to join
- Pathologically confirmed gastric neoplasm
Who cannot join
- Age < 20
- History of gastric surgery
- Severe systemic disease
- Advanced chronic liver disease
- Recent history of upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm
Endoscopic submucosal dissection (ESD) for early gastric cancer is a widely accepted treatment option of expanded indication worldwide.
ESD is relatively difficult compared with endoscopic mucosal resection, thus, proper training is essential for the safe performance of the procedure. Thus, it is necessary to receive proper training in the procedure for safe performance of ESD. Previous studies reported that there was a learning curve in ESD training and preceptees needed to perform at least 30-40 procedures in order to master this technique. However, there is few study about the association between the clinical characteristics and competence level for gastric ESD.
Read the detailed description
This study aims to evaluate the clinical outcomes of ESD and to describe the learning curve for ESD of the gastric neoplasm, based on the analysis of a single endoscopist's experience.
- Conditions
- Endoscopic Submucosal Dissection, Gastric Neoplasm
- Being tested
- Endoscopic submucosal dissection
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissectionProcedure or surgery
ESD was performed under conscious sedation. For sedation, midazolam and/or propofol were administered intravenously, with cardiorespiratory monitoring. Initially, indigo carmine dye was sprayed onto the tumor to clarify the margin. Then, markings were made 10 mm outside the tumor margin using argon plasma coagulation. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine was injected into the submucosa outside the marking dots. Circumferential mucosal incision and submucosal dissection were performed using a Dual and/or IT knife. During the procedure, immediate bleeding was treated by Coagrasper. After ESD, chest and abdominal plain radiography were performed routinely for detection of gastric perforation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Resection speed
Defined as resected lesion size divided by ESD procedure time
Measured: 4 weeks
Secondary outcomes (1)
Complication rate
ESD-related bleeding, gastric perforation, patient's death
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Mar 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal DissectionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soonchunhyang University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun-Hyung Cho, Soonchunhyang University Hospital
- Investigators
- Jun-Hyung Cho, M.D., Principal investigator, Soonchunhyang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265221
- Sponsor's protocol ID
- SCH-ESD-2022
- Status last verified
- Jun 2022
- First submitted
- 22 Feb 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm
- ClinicalTrials.gov ID
- NCT05265221
- Acronym / sponsor ID
- SCH-ESD-2022
- Conditions
- Endoscopic Submucosal Dissection, Gastric Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Soonchunhyang University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 3 Mar 2022 (actual)
- 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) for early gastric cancer is a widely accepted treatment option of expanded indication worldwide.
ESD is relatively difficult compared with endoscopic mucosal resection, thus, proper training is essential for the safe performance of the procedure. Thus, it is necessary to receive proper training in the procedure for safe performance of ESD. Previous studies reported that there was a learning curve in ESD training and preceptees needed to perform at least 30-40 procedures in order to master this technique. However, there is few study about the association between the clinical characteristics and competence level for gastric ESD.
Detailed description
This study aims to evaluate the clinical outcomes of ESD and to describe the learning curve for ESD of the gastric neoplasm, based on the analysis of a single endoscopist's experience.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who underwent endoscopic dissection due to gastric neoplasms
Key inclusion criteria (1 listed)
- Pathologically confirmed gastric neoplasm
Key exclusion criteria (5 listed)
- Age < 20
- History of gastric surgery
- Severe systemic disease
- Advanced chronic liver disease
- Recent history of upper gastrointestinal bleeding
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 |
|---|---|---|
| Endoscopic submucosal dissectionESD was performed under conscious sedation. For sedation, midazolam and/or propofol were administered intravenously, with cardiorespiratory monitoring. Initially, indigo carmine dye was sprayed onto the tumor to clarify the margin. Then, markings were made 10 mm outside the tumor margin using argon plasma coagulation. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine was injected into the submucosa outside the marking dots. Circumferential mucosal incision and submucosal dissection were performed using a Dual and/or IT knife. During the procedure, immediate bleeding was treated by Coagrasper. After ESD, chest and abdominal plain radiography were performed routinely for detection of gastric perforation. | Procedure or surgery | – |
Primary outcome
Resection speed
Time frame: 4 weeks
Defined as resected lesion size divided by ESD procedure time
1 secondary outcome
Complication rate
Time frame: 4 weeks
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 Jun 2022.
- Individual participant dataSharing planned: No
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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.
Jun-Hyung Cho, M.D. principal investigator
Soonchunhyang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Submucosal Dissection and Gastric Neoplasm, run by Soonchunhyang 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 1 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: finished, as of the sponsor's last update on 30 Jun 2022. 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?
Resection speed (time frame: 4 weeks). 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 30 Jun 2022.