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NCT Number: NCT03857737

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

Location contact

Shigang Ding, MD

CONTACT

Shigang Ding, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic submucosal dissection

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

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.

Primary outcomes

  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 outcomes

  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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shigang Ding, MD

CONTACT

[email protected]

+8618800105276

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2029
Study completion
2029
First posted
Feb 28, 2019
Registry last updated
Feb 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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