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

• ClinicalTrials.gov Identifier: NCT03857737
• Recruitment Status: Not yet recruiting
• First Posted: February 28, 2019
• Last Update Posted: February 28, 2019
• Sponsor: Peking University Third Hospital
• Information provided by (Responsible Party): Shigang Ding, Peking University Third Hospital

Tracking Information

• First Submitted Date: February 25, 2019
• First Posted Date: February 28, 2019
• Last Update Posted Date: February 28, 2019
• Estimated Study Start Date: March 1, 2019
• Estimated Primary Completion Date: December 31, 2029 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Endoscopic Submucosal Dissection Versus Surgery in the Treatment of Early Gastric Cancer
• 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Early Gastric Cancer

Intervention

• 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

• 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 *

• 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.
• Suzuki 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.
• Bray 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. Erratum in: CA Cancer J Clin. 2020 Jul;70(4):313.
• Pimentel-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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: February 27, 2019): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2029
• Estimated Primary Completion Date: December 31, 2029 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No

Contacts

Contact: Shigang Ding, MD; +8618800105276; 18800105276@163.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03857737
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Shigang Ding, Peking University Third Hospital
• Study Sponsor: Peking University Third Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Peking University Third Hospital
• Verification Date: February 2019