The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
NCT ID: NCT05323929
Last Updated: 2022-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2022-01-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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deep ESD group
Performed according to the ESD standard procedure, the depth of dissection includes the SM3 layer (submucosa 1/3 layer)
ESD
Endoscopic Submucosal Dissection for early gastric cancer
shallow ESD group
Performed according to the ESD standard procedure, the depth of dissection does not include the SM3 layer (submucosa 1/3 layer)
ESD
Endoscopic Submucosal Dissection for early gastric cancer
Interventions
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ESD
Endoscopic Submucosal Dissection for early gastric cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Xinliang Lu, professor
Role: STUDY_DIRECTOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Locations
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Second affiliated hospital, school of medicine, Zhejiang University
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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. doi: 10.1136/gut.47.5.618.
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.
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.
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.
Other Identifiers
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2021-0634
Identifier Type: -
Identifier Source: org_study_id
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