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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2027
  • participants needed
    200
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 1 May 2022

Summary

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.

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.

Details
Condition Early Gastric Cancer, Endoscopic Submucosal Dissection
Treatment ESD
Clinical Study IdentifierNCT05323929
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on1 May 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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