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

Early Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03857737
• Other study ID #: PUTH020301ESD
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 31, 2029

Study information

• Verified date: February 2019
• Source: Peking University Third Hospital
• Contact: Shigang Ding, MD
• Phone: +8618800105276
• Email: 18800105276[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Early Gastric Cancer
• Stomach Neoplasms

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.
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From March 1 2019 to December 1 2024
Primary	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.	From March 1 2019 to December 1 2024
Secondary	Complication	Complications were classified according to the Clavien-Dindo classification and the frequency of the complications will be compared between the two groups.	From March 1 2019 to December 1 2024