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NCT Number: NCT05323929

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second affiliated hospital, school of medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location status: Recruiting

Location contact

Yuqi Wang, Doctor

CONTACT

[email protected]

+86-15267019821

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

ESD

Procedure

Endoscopic Submucosal Dissection for early gastric cancer

Primary outcomes

  1. scar area

    Time frame: 1 year

    the scar area after ESD for 1 year

Study contacts

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

Yuqi Wang, Doctor

CONTACT

[email protected]

+86-15267019821

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Apr 12, 2022
Registry last updated
Apr 14, 2022

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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