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

Early Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05323929
• Other study ID #: 2021-0634
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuqi Wang, Doctor
• Phone: +86-15267019821
• Email: wyq[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Early Gastric Cancer
• Endoscopic Submucosal Dissection
• Stomach Neoplasms

Intervention

Procedure:
• ESD
Endoscopic Submucosal Dissection for early gastric cancer

Locations

Country	Name	City	State
China	Second affiliated hospital, school of medicine, Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scar area	the scar area after ESD for 1 year	1 year