The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma

April 12, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
This study is a single-center, prospective, group-controlled clinical trial, aiming to clarify the relationship between the depth of dissection and scar formation in the treatment of early gastric cancer by ESD, and to provide high-quality evidence-based medicine for the treatment of early gastric cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This project intends to compare the scar size of ESD for early gastric cancer with different peeling depths, explore the relationship between ESD peeling depth, scar formation and gastric function, and clarify the differential impact of different peeling depths on the prognosis of patients. We plan to provide evidence for guidelines of early gastric cancer ESD treatment based on the related data. In further, the project show insight into a more effective clinical technique which profit patients better prognosis.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yuqi Wang, Doctor
  • Phone Number: +86-15267019821
  • Email: wyq@zju.edu.cn

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:
          • Yuqi Wang, Doctor
          • Phone Number: +86-15267019821
          • Email: wyq@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients older than 18 years old and younger than 75 years old.
  • Early gastric cancer (T1a stage) diagnosed by gastroscopy or ultrasonography, differentiated and no ulcer; or early gastric cancer (T1a stage), differentiated with ulcer, lesion diameter <3cm; or early gastric cancer (T1a stage), undifferentiated and No ulcer, lesion diameter <2cm.
  • Pathological diagnosis of gastric cancer.
  • No further treatment is required.
  • Patients diagnosed for the first time without other serious gastrointestinal diseases.

Exclusion Criteria:

  • Those who did not comply with the test requirements, obviously violated this protocol, or switched to other protocols in the middle of treatment.
  • Advanced gastric cancer; or undifferentiated gastric cancer lesions > 2 cm in diameter; or differentiated gastric cancer with ulcer lesions > 3 cm in diameter.
  • Coagulation disorders.
  • Serious heart, liver, kidney and other diseases, can not tolerate ESD treatment.
  • Patients with gastric cancer complications such as gastrointestinal bleeding and perforation that need emergency treatment.
  • Patients with distant metastasis.
  • Patients with other tumors, patients with a history of malignant tumors (except early carcinoma in situ.
  • The patient himself requests to withdraw from the trial.
  • The researcher believes that the patient is not suitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: deep ESD group
Performed according to the ESD standard procedure, the depth of dissection includes the SM3 layer (submucosa 1/3 layer)
Procedure: ESD
Endoscopic Submucosal Dissection for early gastric cancer
EXPERIMENTAL: shallow ESD group
Performed according to the ESD standard procedure, the depth of dissection does not include the SM3 layer (submucosa 1/3 layer)
Procedure: ESD
Endoscopic Submucosal Dissection for early gastric cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
scar area
Time Frame: 1 year
the scar area after ESD for 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

  • Study Director: Xinliang Lu, professor, Second Affiliated Hospital, School of Medicine, Zhejiang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2022

Primary Completion (ANTICIPATED)

December 31, 2026

Study Completion (ANTICIPATED)

December 31, 2027

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (ACTUAL)

April 12, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 12, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0634

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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