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

Zhejiang University

Status: Enrolling

Conditions: Early Gastric Cancer; Endoscopic Submucosal Dissection

Treatments: Procedure: ESD

Study type: Interventional

Funder types: Other

Identifiers

NCT05323929

2021-0634

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 2 patient groups

deep ESD group

Experimental group

Description:

Performed according to the ESD standard procedure, the depth of dissection includes the SM3 layer (submucosa 1/3 layer)

Treatment:

Procedure: ESD

shallow ESD group

Experimental group

Description:

Performed according to the ESD standard procedure, the depth of dissection does not include the SM3 layer (submucosa 1/3 layer)

Treatment:

Procedure: ESD