NCT03857737

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2019Dec 2029

First Submitted

Initial submission to the registry

February 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

February 28, 2019

Status Verified

February 1, 2019

Enrollment Period

10.8 years

First QC Date

February 25, 2019

Last Update Submit

February 27, 2019

Conditions

Early Gastric Cancer

Keywords

early gastric cancerendoscopic submucosal dissectionsurgery

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Complication

    From March 1 2019 to December 1 2024

Study Arms (2)

ESD group

EXPERIMENTAL

This group include patients who are going to undergo endoscopic submucosal dissection for early gastric cancer.

Procedure: endoscopic submucosal dissection

Surgery group

ACTIVE COMPARATOR

This group include patients who are going to undergo surgery for early gastric cancer.

Procedure: Surgery

Interventions

endoscopic submucosal dissectionPROCEDURE

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.

ESD group
SurgeryPROCEDURE

Surgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons.

Surgery group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

Location

Related Publications (4)

  • 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. No abstract available.

    PMID: 27342689BACKGROUND

  • 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.

    PMID: 27722825BACKGROUND

  • 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.

    PMID: 30207593BACKGROUND

  • 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.

    PMID: 26317585BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal ResectionSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresMinimally Invasive Surgical Procedures

Central Study Contacts

Shigang Ding, MD

CONTACT

+861880010527618800105276@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending, Chief of the Gastrointestinal Department of Peking University Third Hospital

Study Record Dates

First Submitted

February 25, 2019

First Posted

February 28, 2019

Study Start

March 1, 2019

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

February 28, 2019

Record last verified: 2019-02

Locations

CN(1)