The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- scar area [1 year]
the scar area after ESD for 1 year
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients older than 18 years old and younger than 75 years old.
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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.
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Pathological diagnosis of gastric cancer.
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No further treatment is required.
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Patients diagnosed for the first time without other serious gastrointestinal diseases.
Exclusion Criteria:
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Those who did not comply with the test requirements, obviously violated this protocol, or switched to other protocols in the middle of treatment.
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Advanced gastric cancer; or undifferentiated gastric cancer lesions > 2 cm in diameter; or differentiated gastric cancer with ulcer lesions > 3 cm in diameter.
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Coagulation disorders.
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Serious heart, liver, kidney and other diseases, can not tolerate ESD treatment.
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Patients with gastric cancer complications such as gastrointestinal bleeding and perforation that need emergency treatment.
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Patients with distant metastasis.
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Patients with other tumors, patients with a history of malignant tumors (except early carcinoma in situ.
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The patient himself requests to withdraw from the trial.
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The researcher believes that the patient is not suitable to participate in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second affiliated hospital, school of medicine, Zhejiang University | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Study Director: Xinliang Lu, professor, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Documents (Full-Text)
None provided.More Information
Publications
- Chung IK, Lee JH, Lee SH, Kim SJ, Cho JY, Cho WY, Hwangbo Y, Keum BR, Park JJ, Chun HJ, Kim HJ, Kim JJ, Ji SR, Seol SY. Therapeutic outcomes in 1000 cases of endoscopic submucosal dissection for early gastric neoplasms: Korean ESD Study Group multicenter study. Gastrointest Endosc. 2009 Jun;69(7):1228-35. doi: 10.1016/j.gie.2008.09.027. Epub 2009 Feb 27.
- Ono H, Yao K, Fujishiro M, Oda I, Uedo N, Nimura S, Yahagi N, Iishi H, Oka M, Ajioka Y, Fujimoto K. Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer (second edition). Dig Endosc. 2021 Jan;33(1):4-20. doi: 10.1111/den.13883. Epub 2020 Dec 9. Review.
- Russo AE, Strong VE. Gastric Cancer Etiology and Management in Asia and the West. Annu Rev Med. 2019 Jan 27;70:353-367. doi: 10.1146/annurev-med-081117-043436. Epub 2018 Oct 24. Review.
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Toyonaga T, Man-i M, East JE, Nishino E, Ono W, Hirooka T, Ueda C, Iwata Y, Sugiyama T, Dozaiku T, Hirooka T, Fujita T, Inokuchi H, Azuma T. 1,635 Endoscopic submucosal dissection cases in the esophagus, stomach, and colorectum: complication rates and long-term outcomes. Surg Endosc. 2013 Mar;27(3):1000-8. doi: 10.1007/s00464-012-2555-2. Epub 2012 Oct 6.
- Tsukuma H, Oshima A, Narahara H, Morii T. Natural history of early gastric cancer: a non-concurrent, long term, follow up study. Gut. 2000 Nov;47(5):618-21.
- 2021-0634