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

NCT ID: NCT03857737

Last Updated: 2019-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2029-12-31

Brief Summary

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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

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Conditions

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Early Gastric Cancer

Keywords

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early gastric cancer endoscopic submucosal dissection surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESD group

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

Group Type EXPERIMENTAL

endoscopic submucosal dissection

Intervention Type PROCEDURE

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 group

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

Group Type ACTIVE_COMPARATOR

Surgery

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Shigang Ding

Attending, Chief of the Gastrointestinal Department of Peking University Third Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Central Contacts

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Shigang Ding, MD

Role: CONTACT

Phone: +8618800105276

Email: [email protected]

Facility Contacts

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Shigang Ding, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 27342689 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27722825 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30207593 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26317585 (View on PubMed)

Other Identifiers

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PUTH020301ESD

Identifier Type: -

Identifier Source: org_study_id