Early Gastric CancerNCT03857737
Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer
A study testing endoscopic submucosal dissection and Surgery in people with Early Gastric Cancer, run by Peking University Third Hospital at 1 site in China.
Trial summary
In this study, patients who are going to undergo endoscopic submucosal dissection (ESD) or surgery for early gastric cancer will be enrolled and divided into ESD group and Surgery group according to the procedure they go through. The patients will be followed up for at least 5 years after ESD or surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Early Gastric Cancer
- What is being tested?
- endoscopic submucosal dissection and Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinically diagnosed as early gastric cancer
- Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
Who cannot join
- Advanced stage gastric cancer
- Not willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
- Not willing to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100091
Shigang Ding, MD
Shigang Ding, MD
About this study
Official title: A Study Which Compares the Long Term and Short Term Outcomes Between Endoscopic Submucosal Dissection and Surgery in the Treatment of Early Gastric Cancer
In this study, patients who are going to undergo endoscopic submucosal dissection (ESD) or surgery for early gastric cancer will be enrolled and divided into ESD group and Surgery group according to the procedure they go through. The patients will be followed up for at least 5 years after ESD or surgery. Esophagogastroduodenoscopy (EDG) and biopsy will be performed 3 months and then 6 months after ESD or surgery. Thereafter, EDG will be performed along with biopsy and abdominal computed tomography annually up to 5 years. Patients' data such as age, sex, clinical diagnosis, achievement of en-bloc resection, pathological outcomes, complications and survival condition will be prospectively collected. Statistical methods such as Student's t-test, the chi-square test, the Kaplan-Meier method and the log-rank test will be used to compare the short term and long term outcomes between the ESD group and the surgery group.
- Conditions
- Early Gastric Cancer
- Being tested
- endoscopic submucosal dissection, Surgery
- Keywords
- early gastric cancer, endoscopic submucosal dissection, surgery
- 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
Endoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists.
SurgeryProcedure or surgery
Surgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons.
| Study group | Role | What they receive |
|---|---|---|
| ESD group | Experimental | This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer. Receives: Procedure: endoscopic submucosal dissection |
| Surgery group | Active comparator | This group include patients who are going to undergo surgery for early gastric cancer. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year OS
5-year OS is the five year overall survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test.
Measured: From March 1 2019 to December 1 2024
5-year DSS
5-year DSS is the five year disease specific survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test.
Measured: From March 1 2019 to December 1 2024
Secondary outcomes (1)
Complication
Complications were classified according to the Clavien-Dindo classification and the frequency of the complications will be compared between the two groups.
Measured: From March 1 2019 to December 1 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Mar 2019 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (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 CancerStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shigang Ding, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857737
- Sponsor's protocol ID
- PUTH020301ESD
- Status last verified
- Feb 2019
- First submitted
- 25 Feb 2019
- Last updated
- 28 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
PubMed 27342689Suzuki H, Oda I, Abe S, Sekiguchi M, Nonaka S, Yoshinaga S, Saito Y, Fukagawa T, Katai H. Clinical outcomes of early gastric cancer patients after noncurative endoscopic submucosal dissection in a large consecutive patient series. Gastric Cancer. 2017 Jul;20(4):679-689. doi: 10.1007/s10120-016-0651-z. Epub 2016 Oct 8.
PubMed 27722825Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T, Repici A, Vieth M, De Ceglie A, Amato A, Berr F, Bhandari P, Bialek A, Conio M, Haringsma J, Langner C, Meisner S, Messmann H, Morino M, Neuhaus H, Piessevaux H, Rugge M, Saunders BP, Robaszkiewicz M, Seewald S, Kashin S, Dumonceau JM, Hassan C, Deprez PH. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Sep;47(9):829-54. doi: 10.1055/s-0034-1392882. Epub 2015 Aug 28.
PubMed 26317585
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Which Compares the Long Term and Short Term Outcomes Between Endoscopic Submucosal Dissection and Surgery in the Treatment of Early Gastric Cancer
- ClinicalTrials.gov ID
- NCT03857737
- Acronym / sponsor ID
- PUTH020301ESD
- Conditions
- Early Gastric Cancer
- Keywords
- early gastric cancer, endoscopic submucosal dissection, surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 28 Feb 2019 (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.
In this study, patients who are going to undergo endoscopic submucosal dissection (ESD) or surgery for early gastric cancer will be enrolled and divided into ESD group and Surgery group according to the procedure they go through. The patients will be followed up for at least 5 years after ESD or surgery. Esophagogastroduodenoscopy (EDG) and biopsy will be performed 3 months and then 6 months after ESD or surgery. Thereafter, EDG will be performed along with biopsy and abdominal computed tomography annually up to 5 years. Patients' data such as age, sex, clinical diagnosis, achievement of en-bloc resection, pathological outcomes, complications and survival condition will be prospectively collected. Statistical methods such as Student's t-test, the chi-square test, the Kaplan-Meier method and the log-rank test will be used to compare the short term and long term outcomes between the ESD group and the surgery group.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESD group | Experimental | Procedure: endoscopic submucosal dissectionThis group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer. |
| Surgery group | Active comparator | Procedure: SurgeryThis group include patients who are going to undergo surgery for early gastric cancer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinically diagnosed as early gastric cancer
- Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
Key exclusion criteria (3 listed)
- Advanced stage gastric cancer
- Not willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer
- Not willing to participate in this study
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 dissectionEndoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists. | Procedure or surgery | ESD group |
| SurgerySurgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons. | Procedure or surgery | Surgery group |
Primary outcome
5-year OS
Time frame: From March 1 2019 to December 1 2024
5-year OS is the five year overall survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test.
5-year DSS
Time frame: From March 1 2019 to December 1 2024
5-year DSS is the five year disease specific survival of each individual group. It will be estimated by Kaplan-Meier method, and statistical significance of differences between the two groups will be assessed using the log-rank test.
1 secondary outcome
Complication
Time frame: From March 1 2019 to December 1 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2019.
- Background: PubMed 27342689Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.
- Background: PubMed 27722825Suzuki H, Oda I, Abe S, Sekiguchi M, Nonaka S, Yoshinaga S, Saito Y, Fukagawa T, Katai H. Clinical outcomes of early gastric cancer patients after noncurative endoscopic submucosal dissection in a large consecutive patient series. Gastric Cancer. 2017 Jul;20(4):679-689. doi: 10.1007/s10120-016-0651-z. Epub 2016 Oct 8.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 26317585Pimentel-Nunes P, Dinis-Ribeiro M, Ponchon T, Repici A, Vieth M, De Ceglie A, Amato A, Berr F, Bhandari P, Bialek A, Conio M, Haringsma J, Langner C, Meisner S, Messmann H, Morino M, Neuhaus H, Piessevaux H, Rugge M, Saunders BP, Robaszkiewicz M, Seewald S, Kashin S, Dumonceau JM, Hassan C, Deprez PH. Endoscopic submucosal dissection: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2015 Sep;47(9):829-54. doi: 10.1055/s-0034-1392882. Epub 2015 Aug 28.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoscopic submucosal dissection and Surgery in people with Early Gastric Cancer, run by Peking University Third Hospital at 1 site in China.
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: opening soon, as of the sponsor's last update on 28 Feb 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shigang Ding, MD (+8618800105276, 18800105276@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
5-year OS (time frame: From March 1 2019 to December 1 2024). The study lists 2 primary outcomes in all. 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 NCT03857737, 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 28 Feb 2019.