Clinical trial · Interventional
The Relationship Between Scar Formation and ESD Depth in Therapy for Gastric Carcinoma
NCT05323929CI-TRIAL-00057792recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
| Endoscopic Submucosal Dissection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESD | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- deep ESD group
- description
- Performed according to the ESD standard procedure, the depth of dissection includes the SM3 layer (submucosa 1/3 layer)
- interventionNames
- Procedure: ESD
- type
- EXPERIMENTAL
- label
- shallow ESD group
- description
- Performed according to the ESD standard procedure, the depth of dissection does not include the SM3 layer (submucosa 1/3 layer)
- interventionNames
- Procedure: ESD
Primary outcomes (1)
- measure
- scar area
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (6)
- BACKGROUNDSung 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. PMID 33538338
- BACKGROUNDRusso 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. PMID 30355265
- BACKGROUNDTsukuma 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. PMID 11034575
- BACKGROUNDToyonaga 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. PMID 23052530
- BACKGROUNDOno 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. PMID 33107115
- BACKGROUNDChung 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. PMID 19249769