Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer
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|ClinicalTrials.gov Identifier: NCT03857737|
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Early Gastric Cancer||Procedure: endoscopic submucosal dissection Procedure: Surgery||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Estimated Study Start Date :||March 1, 2019|
|Estimated Primary Completion Date :||December 31, 2029|
|Estimated Study Completion Date :||December 31, 2029|
Experimental: ESD group
This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer.
Procedure: endoscopic submucosal dissection
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.
Active Comparator: Surgery group
This group include patients who are going to undergo surgery for early gastric cancer.
Surgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons.
- 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.
- Complication [ Time Frame: From March 1 2019 to December 1 2024 ]Complications were classified according to the Clavien-Dindo classification and the frequency of the complications will be compared between the two groups.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03857737
|Contact: Shigang Ding, MDemail@example.com|
|Peking University Third Hospital|
|Beijing, Beijing, China, 100091|
|Contact: Shigang Ding, MD|
|Principal Investigator: Shigang Ding, MD|