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Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03857737
Recruitment Status : Not yet recruiting
First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Shigang Ding, Peking University Third Hospital

Tracking Information
First Submitted Date  ICMJE February 25, 2019
First Posted Date  ICMJE February 28, 2019
Last Update Posted Date February 28, 2019
Estimated Study Start Date  ICMJE March 1, 2019
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 27, 2019)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer
Official Title  ICMJE A Study Which Compares the Long Term and Short Term Outcomes Between Endoscopic Submucosal Dissection and Surgery in the Treatment of Early Gastric Cancer
Brief 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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early Gastric Cancer
Intervention  ICMJE
  • 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.
  • Procedure: 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 Arms  ICMJE
  • Experimental: ESD group
    This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer.
    Intervention: Procedure: endoscopic submucosal dissection
  • Active Comparator: Surgery group
    This group include patients who are going to undergo surgery for early gastric cancer.
    Intervention: Procedure: Surgery
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 27, 2019)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2029
Estimated Primary Completion Date December 31, 2029   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically diagnosed as early gastric cancer
  • Willing to undergo endoscopic submucosal dissection or surgery for the treatment of early gastric cancer

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shigang Ding, MD +8618800105276 18800105276@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03857737
Other Study ID Numbers  ICMJE PUTH020301ESD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shigang Ding, Peking University Third Hospital
Study Sponsor  ICMJE Peking University Third Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Peking University Third Hospital
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP