Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.

Condition or disease Intervention/treatment Phase
Early Gastric Cancer Procedure: endoscopic submucosal dissection Procedure: Surgery Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Shigang Ding, MD +8618800105276 18800105276@163.com

Locations
Layout table for location information
China, Beijing
Peking University Third Hospital
Beijing, Beijing, China, 100091
Contact: Shigang Ding, MD         
Principal Investigator: Shigang Ding, MD         
Sponsors and Collaborators
Peking University Third Hospital
Publications:
Layout table for additonal information
Responsible Party: Shigang Ding, Attending, Chief of the Gastrointestinal Department of Peking University Third Hospital, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03857737    
Other Study ID Numbers: PUTH020301ESD
First Posted: February 28, 2019    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shigang Ding, Peking University Third Hospital:
early gastric cancer
endoscopic submucosal dissection
surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases